Manufacturer's By Name

Manufacturer Address Authorised Representative/UK Responsible Person Relationship Address Date Registered MHRA Reference Number Devices
National Dental Supplies Ltd.Unit 8-9 A K Business Park Russell Road

Southport
Merseyside PR9 7SA

United Kingdom







04/02/2022621
  • Denture base resin kit :
National Diagnostic Products (Australia) Pty LtdNational Diagnostic Products (Australia) Pty Ltd Suite 503 7-9 Merriwa Street

Gordon
NSW 2072

Australia

BETACHEK (UK) LIMITEDUK Responsible Person7 Bell Yard

London
WC2A 2JR
UK Responsible Person
England United Kingdom
11/16/202118389
  • Glucose monitoring system IVD home-use :
National Display Surgical Imaging LLC5750 Hellyer Avenue

San Jose
CA 95138

United States

4 Medical IT LimitedUK Responsible Person2 Diamond Close

Cambridge
Cambridge CB2 8AU
UK Responsible Person
England United Kingdom
03/20/202212776
  • Endoscopic video image processing unit :
National Health Service Greater Glasgow & Clyde (Decontamination)Level 2 Dental Central Decontamination Unit
378 Sauchiehall Street Glasgow
Glasgow
G2 3JZ

United Kingdom







02/05/20198244
  • Dental delivery system instrument unit electric :
  • ,
  • General surgical procedure kit non-medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental mirror reusable :
  • ,
  • Dental material application tool reusable :
National Institute for Biological Standards and Control (NIBSC)Blanche Lane South Mimms

Potters Bar
Hertfordshire EN6 3QG

United Kingdom







02/07/20172
  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD control :
  • ,
  • Hepatitis C virus total antibody IVD control :
  • ,
  • Adenovirus nucleic acid IVD reagent :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD reagent :
  • ,
  • Hepatitis B virus antigen/antibody marker IVD reagent :
  • ,
  • HSV - NA Reagents :
  • ,
  • Other Monogenetic Disorders Tests :
  • ,
  • Measles - NA Reagents :
  • ,
  • Varicella Zoster Virus IgG :
  • ,
  • Other Virology - NA Reagents :
  • ,
  • HIV1 antibody IVD control :
  • ,
  • HIV2 antibody IVD control :
  • ,
  • Hepatitis C virus total antibody IVD control :
  • ,
  • Hepatitis B virus surface antigen IVD control :
  • ,
  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD control :
  • ,
  • Hepatitis B virus e-antigen total antibody IVD control :
  • ,
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Rubella virus immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Antisera matrix (non-reactive) IVD control :
  • ,
  • Ferritin IVD control :
  • ,
  • HLA class I & II antibody screening IVD control :
  • ,
  • Hepatitis B virus core total antibody IVD control :
  • ,
  • Hepatitis B virus surface total antibody IVD control :
  • ,
  • Anti-Rh(D) standard reference solution IVD :
  • ,
  • Anti-C [RH004] standard reference solution IVD :
  • ,
  • HIV2 antibody IVD control :
  • ,
  • Human T-cell lymphotrophic virus 1 (HTLV1) antibody IVD control :
  • ,
  • Hepatitis C virus total antibody IVD control :
  • ,
  • Hepatitis B virus surface antigen IVD control :
  • ,
  • Multiple respiratory virus nucleic acid IVD control :
  • ,
  • SARS-CoV-2 nucleic acid IVD control :
  • ,
  • HIV1 antigen IVD control :
  • ,
  • HLA class I & II antibody screening IVD reagent :
  • ,
  • Other Virology Controls - Inf.Imm :
  • ,
  • Bacterial toxin IVD reagent :
  • ,
  • Multiple respiratory virus nucleic acid IVD reagent :
  • ,
  • HIV1 nucleic acid IVD reagent :
  • ,
  • HLA class I & II antibody screening IVD reagent :
  • ,
  • HLA-DR antigen nucleic acid tissue typing IVD control :
  • ,
  • Human metapneumovirus (hMPV) nucleic acid IVD reagent :
  • ,
  • Haemophilus influenzae culture isolate nucleic acid IVD reagent :
  • ,
  • Norovirus nucleic acid IVD reagent :
  • ,
  • Anti-CDE red blood cell grouping IVD antibody :
  • ,
  • Cytomegalovirus (CMV) nucleic acid IVD reagent :
  • ,
  • Rubella virus immunoglobulin G (IgG) antibody IVD reagent :
  • ,
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD reagent :
  • ,
  • Parvovirus B19 nucleic acid IVD reagent :
  • ,
  • Respiratory syncytial virus (RSV) nucleic acid IVD reagent :
  • ,
  • HIV1/HIV2 antibody IVD reagent :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD reagent :
  • ,
  • Rubella virus total antibody IVD reagent :
  • ,
  • Rhinovirus nucleic acid IVD reagent :
  • ,
  • Human parechovirus (HPeV) nucleic acid IVD reagent :
  • ,
  • Parasitology Controls - Inf.Imm :
  • ,
  • Multiple meningitis-associated bacteria antigen IVD calibrator :
  • ,
  • CD4 cell marker IVD antibody :
  • ,
  • Hepatitis A virus nucleic acid IVD control :
  • ,
  • T lymphocyte IVD control :
  • ,
  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD control :
  • ,
  • HIV1 antibody IVD control :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Parvovirus B19 immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Rubella virus immunoglobulin M (IgM) antibody IVD reagent :
  • ,
  • Measles virus nucleic acid IVD reagent :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD reagent :
  • ,
  • Rubella Virus IgM :
  • ,
  • Hepatitis A virus total antibody IVD control :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Measles virus immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Mumps virus immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Negative control immunoglobulin IVD :
  • ,
  • Hereditary nonpolyposis colon cancer (HNPCC) IVD control :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Multiple immunocompromised host infection-associated virus nucleic acid IVD control :
  • ,
  • Multiple respiratory virus nucleic acid IVD control :
  • ,
  • Coxsackie B virus nucleic acid IVD control :
  • ,
  • Zika virus nucleic acid IVD control :
  • ,
  • Plasmodium falciparum immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Treponema pallidum immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Hepatitis A virus total antibody IVD control :
  • ,
  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Hereditary nonpolyposis colon cancer (HNPCC) IVD control :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Hepatitis E virus immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Hepatitis E virus immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Epstein-Barr virus (EBV) antigen IVD control :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD control :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD control :
  • ,
  • Hepatitis C Virus - NA reagents :
National Services ScotlandGyle Square 1 South Gyle Crescent
Edinburgh
Edinburgh
EH12 9EB

Scotland United Kingdom







02/18/202112226
  • General specimen collection kit :
  • ,
  • General specimen collection kit :
Natrinza Ceramics Ltd5 Hedingham Road Chafford Hundred

Grays
Essex RM16 6BH

United Kingdom







04/07/20224625
  • Dental Appliances/Prostheses :
NaturalCycles Nordic ABSt Eriksgatan 63b,,,

Stockholm
11234

Sweden

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/11/202118199
  • Self-care monitoring/reporting software :
Naturalistic Dental7 Hollowtree Road Hamilton

Leicester
Leicestershire LE5 1TH

England United Kingdom







04/08/20224861
  • Dental Appliances/Prostheses :
Naturelle Consumer Products Ltd5 Bankmore Way East East Industrial Park

Omagh
County Tyrone BT79 0NZ

Northern Ireland United Kingdom







11/23/20062962
  • Examination/Procedure Gloves :
  • ,
  • First Aid Kits :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Medical device cleaning/disinfection wipe :
  • ,
  • Skin-cleaning wipe non-sterile :
Naturs Design Inc.274 W Cortland St.

Jackson Michigan
49201

United States

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
05/08/202114547
  • General-purpose medical fibre padding :
Naturs Design Inc.274 W Cortland St.

Jackson
Michigan 49201

United States

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
05/13/202114649
  • General-purpose medical fibre padding :
Natus Manufacturing Ltd.IDA Business Park

Gort
Co. Galway H91 PD92

Ireland

Natus Nicolet Uk LtdUK Responsible PersonBaynards Green Trading Estate
Prospect House
Bicester
Oxfordshire OX27 7SG
UK Responsible Person
England United Kingdom
04/15/202216671
  • Nerve-locating system :
  • ,
  • Analytical scalp electrode reusable :
  • ,
  • Analytical non-scalp cutaneous lead :
  • ,
  • Electromyograph :
  • ,
  • Electromyographic needle electrode single-use :
  • ,
  • Neurophysiologic monitoring system :
Natus Medical DenmarkHoerskaetten 9

Taastrup
2630

Denmark

Natus Nicolet Uk LtdUK Responsible PersonBaynards Green Trading Estate
Prospect House
Bicester
Oxfordshire OX27 7SG
UK Responsible Person
England United Kingdom
04/15/202216670
  • Diagnostic caloric vestibular stimulation system :
  • ,
  • Visual evoked-potential graphic recorder :
  • ,
  • Tone audiometer manual :
  • ,
  • Otoscope endoscopic :
  • ,
  • Auditory canal scanner :
  • ,
  • Analytical non-scalp cutaneous electrode :
  • ,
  • Electronystagmograph :
Natus Medical Incorporated5955 Pacific Centre Boulevard

San Diego
CA92121

United States

Natus Nicolet Uk LtdUK Responsible PersonBaynards Green Trading Estate
Prospect House
Bicester
Oxfordshire OX27 7SG
UK Responsible Person
England United Kingdom
04/15/202213774
  • Intracerebral sensor catheter short-term :
  • ,
  • Intracranial pressure monitor :
  • ,
  • Electrical-only medical device connection cable reusable :
Natus Neurology Incorporated2568 Bristol Circle 3150 Pleasant View Road

Oakville
ON L6H 5S1

United States

Natus Nicolet Uk LtdUK Responsible PersonBaynards Green Trading Estate
Prospect House
Bicester
Oxfordshire OX27 7SG
UK Responsible Person
England United Kingdom
04/15/202214265
  • Electroencephalograph :
  • ,
  • Electroencephalograph :
  • ,
  • Sleep disorder interpretive software professional-use :
  • ,
  • Polysomnograph :
  • ,
  • Ophthalmic fundus camera :
  • ,
  • Electroencephalographic monitoring system portable :
  • ,
  • Neurophysiologic monitoring system :
  • ,
  • Visual stimulator :
  • ,
  • Analytical non-scalp cutaneous lead :
  • ,
  • Analytical non-scalp cutaneous electrode :
  • ,
  • Evoked-potential audiometer :
  • ,
  • Blanket/pad infant phototherapy unit :
  • ,
  • Patient positioning vacuum mattress :
  • ,
  • Electroencephalograph :
Natus Neurology Incorporated3150 Pleasant View Road

Middleton
WI 53562

United States

Natus Nicolet Uk LtdUK Responsible PersonBaynards Green Trading Estate
Prospect House
Bicester
Oxfordshire OX27 7SG
UK Responsible Person
England United Kingdom
04/15/202216673
  • Analytical non-scalp cutaneous lead :
  • ,
  • Analytical scalp electrode reusable :
  • ,
  • Electromyograph :
  • ,
  • Electroencephalograph :
  • ,
  • Cortical electrode :
  • ,
  • Analytical non-scalp cutaneous electrode :
  • ,
  • Bioelectrical signal analysis software :
Navbit Pty Ltd.Suite 302 272 Pacific Highway

Crows Nest
NSW 2065

Australia

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
09/15/202117597
  • Orthopaedic stereotactic surgery system :
Navilyst Medical Inc.26 Forest Street

Marlborough
Massachusetts 01752

United States

AngioDynamics UK Ltd.UK Responsible Personc/o Kidd Rapinet LLP 29 Harbour Exchange Square

London
E14 9GE
UK Responsible Person
England United Kingdom
04/13/202214082
  • Peripherally-inserted central venous catheter :
  • ,
  • Double-lumen haemodialysis catheter implantable :
  • ,
  • Biliary drain :
  • ,
  • Closed-wound drain non-bioabsorbable :
  • ,
  • Nephrostomy catheter :
  • ,
  • Peripheral intravenous cannula :
  • ,
  • Peripheral vascular guidewire manual :
  • ,
  • Non-vascular catheter introduction set :
  • ,
  • Vascular catheter introduction set nonimplantable :
  • ,
  • Vascular catheter introduction set nonimplantable :
  • ,
  • Vascular catheter introduction set nonimplantable :
Naviswiss AGStahlrain 2 CH-5200

Brugg
5200

Switzerland

confinis (UK) RP LtdUK Responsible PersonSt John's Innovation Centre Cowley Road

Cambridge
CB4 0WS
UK Responsible Person
England United Kingdom
02/01/202221879
  • Orthopaedic/craniofacial implantation planning software :
  • ,
  • Optical surgical navigation device tracking system :
NBCL B.V.Kerkenbos 1097-C

Nijmegen
Provincie Gelderland 6546 BB

Netherlands

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
04/26/202113724
  • Parathyroid hormone (PTH) IVD calibrator :
  • ,
  • Parathyroid hormone (PTH) IVD control :
  • ,
  • Parathyroid hormone (PTH) IVD kit chemiluminescent immunoassay :
  • ,
  • Chemiluminescent immunoassay analyser IVD automated :
NCS Lab SRLVia Pola Esterna 4/12

Carpi
41012

Italy

Templar Regulatory Consulting Limited UK Responsible PersonNiall House Unit 4 24-26 Boulton Road
Stevenage
Stevenage
Hertfordshire SG14QX
UK Responsible Person
England United Kingdom
05/11/202114609
  • Tendon/ligament bone anchor non-bioabsorbable :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
  • ,
  • Suturing needle single-use :
NDD Medizintechnik AGTechnoparkstrasse 1

Zurich
CH-8005

Switzerland

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
04/14/202217357
  • Pulmonary function analysis system adult :
  • ,
  • Pulmonary function testing filter/mouthpiece :
  • ,
  • Diagnostic spirometer professional :
  • ,
  • Pulmonary function testing filter/mouthpiece :
NDS Ceramics LimitedBiloxi 41a Staincross Common
Staincross Biloxi
Barnsley
South Yorkshire S75 6JF

England United Kingdom

nds.63@hotmail.co.uk






04/07/20224256
  • Custom-made dental crown polymer :
  • ,
  • Ceramic dental inlay :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Dental bridge ceramic :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental veneer professional :
  • ,
  • Orthodontic retainer :
  • ,
  • Root canal post custom-made :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Gold dental inlay :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Preformed dental crown temporary :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant suprastructure permanent custom-made :
NDS Surgical Imaging LLC100 Paramount Dr. Ste 101
100 Paramount Dr. Ste 101
Sarasota
Florida 34232

United States

Novanta Technologies UK LimitedUK Responsible Person29 Holton Road Holton Heath

Poole
Dorset BH16 6LN
UK Responsible Person
England United Kingdom
07/25/202223167
  • Image display monitor colour :
NDS Surgical Imaging LLC100 Paramount Dr. Ste 101
100 Paramount Dr. Ste 101
Sarasota
Florida 34232

United States

Novanta Technologies UK LimitedUK Responsible Person29 Holton Road Holton Heath

Poole
Dorset BH16 6LN
UK Responsible Person
England United Kingdom
07/25/202223168
  • Video camera surgical microscope system :
NDS Surgical Imaging LLC100 Paramount Dr. Ste 101

Sarasota
Florida 34232

United States

Novanta Technologies UK LimitedUK Responsible Person29 Holton Road Holton Heath

Poole
Dorset BH16 6LN
UK Responsible Person
England United Kingdom
07/25/202223169
  • Image display monitor colour :
NDS Surgical Imaging LLC100 Paramount Suite 101
486 Scott Street Sarasota
Fremont
FL 94539

United States

Novanta Technologies UK LimitedUK Responsible Person29 Holton Road Holton Heath

Poole
Dorset BH16 6LN
UK Responsible Person
England United Kingdom
07/25/202223170
  • Medical networking interface unit :
NE Device SW OyTeknologiantie 7b

Oulu
90590

Finland

Vitacam LtdUK Responsible PersonThe Health And Wellbeing Innovation Centre

Truro
Cornwall TR1 3FF
UK Responsible Person
England United Kingdom
moyeen@vitacam.health
07/11/202216957
  • Cardiopulmonary physiologic analysis software :
NEA International B.V.Europalaan 31

Maastricht-Airport
6199 AB

Netherlands

FREYR LIFE SCIENCES LTDUK Responsible Person9 Greyfriars Road

Reading
Berkshire RG1 1NU
UK Responsible Person
England United Kingdom
UKRP@FREYRSOLUTIONS.COM
07/14/202225314
  • Wrist orthosis :
  • ,
  • Ankle/foot orthosis :
  • ,
  • Knee orthosis :
  • ,
  • Lumbar spine orthosis :
  • ,
  • Shoulder immobilizer/orthosis reusable :
  • ,
  • Cervical spine collar reusable :
  • ,
  • Elbow orthosis :
  • ,
  • Wrist/hand/finger stable-position orthosis :
  • ,
  • Hand/finger splint reusable :
Needs LtdUnits 3 - 4 Horsecroft Road
Roydonbury Industrial Estate
Harlow
Essex CM19 5BZ

England United Kingdom
01279626233
r.clewley@needsplastics.co.uk






12/10/20123717
  • Dilators And Lubricants :
  • ,
  • Surgical Instrument Accessories :
  • ,
  • Pelvic-organ-supporting pessary :
Neil Coleman Crown & Bridge361 Unthank Road

Norwich
Norfolk NR4 7QG

United Kingdom







03/19/20091807
  • Ceramic dental inlay :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Resin dental inlay :
  • ,
  • Bar dental precision attachment :
  • ,
  • Bonded dental bridge :
  • ,
  • Preformed dental crown temporary :
  • ,
  • Dental veneer professional :
  • ,
  • Gold dental inlay :
  • ,
  • Partial denture :
  • ,
  • Mouthguard reusable :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Dental appliance fabrication material thermoplastic :
  • ,
  • Overdenture :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Ceramic artificial teeth :
  • ,
  • Preformed complete denture :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Custom-made mouthguard :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental prosthesis veneer resin :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Dental bridge polymer :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
NeilMed Pharmaceuticals Inc.601 Aviation Blvd

Santa Rosa
California 95403

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
02/01/202221758
  • Antimicrobial wound irrigation solution sterile :
  • ,
  • Nasal irrigation set home-use :
  • ,
  • Ear canal irrigation kit single-use :
  • ,
  • Nasal aspirator manual :
  • ,
  • Nasal aspirator manual :
  • ,
  • Nasal mucosa dressing non-antimicrobial :
Neitz Instruments Co. Ltd.4F Ichibancho Court 15-21 Ichibancho

Chiyoda-ku Tokyo
102-0082

Japan

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202219420
  • Surgical binoculars reusable :
  • ,
  • Retinoscope battery-powered :
  • ,
  • Direct ophthalmoscope :
  • ,
  • Indirect monocular ophthalmoscope :
  • ,
  • Indirect binocular ophthalmoscope :
  • ,
  • Head-worn lamp :
Nemaura Pharma5 Oakwood Drive Loughborough University Science and Enterprise Park 5 Oakwood Drive

Loughborough
Leicestershire LE11 3QF

United Kingdom







02/03/20176184
  • Noninvasive interstitial-fluid glucose monitoring device :
  • ,
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Noninvasive interstitial-fluid glucose monitoring device :
  • ,
  • Noninvasive interstitial-fluid glucose monitoring device :
Nemoto Kyorindo Co Ltd2-27-20 Hongo Bunkyo-ku

Tokyo
113-0033

Japan

MIS Healthcare LtdUK Responsible PersonUnit 26-27 Capitol Way Capitol Park

London
NW9 0EQ
UK Responsible Person
England United Kingdom
02/07/202222720
  • MRI contrast medium injection system line-powered mobile :
  • ,
  • CT contrast medium injection system line-powered mobile :
  • ,
  • Angiography contrast medium injection system line-powered mobile :
  • ,
  • Angiography contrast medium injection system line-powered stationary :
  • ,
  • Topical coupling gel non-sterile :
  • ,
  • Contrast medium injection system control unit :
Neo-Innovations UK LTD35-37 Ludgate Hill Office Number 7
London
London
EC4M 7JN

England United Kingdom







05/03/202224484
  • Assistive sock/pantyhose dressing device :
Neo-nostics (Suzhou) Bioengineering Co. Ltd.2F #3 Building #52 Yin Gang Road Taicang Suzhou City

Jiangsu Province
215434

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
06/22/202115322
  • SARS-CoV-2 neutralizing antibody IVD kit rapid ICT clinical :
NEO Dr. INC.#2-204 205 Medical Industry Complex 42-10 Taejanggongdan-gil

Wonju-si
Gangwond-do 26311

South Korea

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
03/18/202223675
  • Polyester suture bioabsorbable monofilament non-antimicrobial :
  • ,
  • Acupuncture needle single-use :
Neo G LimitedBuilding A Knaresborough Technology Park Manse Lane

Knaresborough
Yorkshire HG5 8LF

England United Kingdom







08/30/20135411
  • Orthoses (Lower And Upper Limb/Spinal/Abdominal/Neck/Head) :
  • ,
  • Orthopaedic Footware :
  • ,
  • Trusses :
  • ,
  • Compression Hosiery/Garments :
  • ,
  • Orthopaedic Casting/Support Products And Accessories :
  • ,
  • Bunion shield :
  • ,
  • Abdominal hernia truss reusable :
  • ,
  • Cervical spine collar reusable :
  • ,
  • Clavicle orthosis :
  • ,
  • Compression/pressure sock/stocking reusable :
  • ,
  • Finger/hand exerciser :
  • ,
  • Finger protector reusable :
  • ,
  • Foot friction/impact protector :
  • ,
  • Hallux valgus metatarsophalangeal orthosis :
  • ,
  • Hip/knee/ankle/foot orthosis :
  • ,
  • Hot/cold therapy pack reusable :
  • ,
  • Hypoallergenic skin adhesive tape :
  • ,
  • Insulation bandage :
  • ,
  • Lumbosacral spine orthosis flexible :
  • ,
  • Pressure bandage Hevea-latex reusable :
  • ,
  • Sacroiliac spine orthosis :
  • ,
  • Shoulder/elbow/wrist/hand orthosis :
  • ,
  • Compression/pressure glove :
  • ,
  • Pressure-management sock :
  • ,
  • Abdominal binder reusable :
  • ,
  • Breast binder reusable :
  • ,
  • Orthotic insole prefabricated antimicrobial :
  • ,
  • Pressure-management insole prefabricated :
  • ,
  • Compression/pressure sock/stocking single-use :
  • ,
  • Orthotic insole prefabricated non-antimicrobial :
  • ,
  • Cold/cool therapy gel :
  • ,
  • Skin-cover adhesive strip non-antimicrobial :
Neo Q Quality In Imaging GmbH4
Oranienburger Str. Berlin
Berlin
Berlin 10178

Germany

Medical Device Commercial ConsultingUK Responsible PersonWood Lodge Iron Row Burley In Wharfedale

ILKLEY
West Yorkshire LS29 7DB
UK Responsible Person
England United Kingdom
02/01/202222004
  • Clinical management support software :
Neobiotech Co. Ltd.(HO & Factory 1) #104 24 / #102 103 104-1 105 106 205 212 306 312 509 510 511 608 704 708 710 & 10F 36 digital-ro 27gil

Seoul
Guro-gu 08381

South Korea

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
06/18/202115389
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant system :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit medicated reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental drill bit extension :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental/maxillofacial surgical procedure kit medicated reusable :
  • ,
  • Dental implant system :
  • ,
  • Dental prosthesis/implant abutment screw analog single-use :
  • ,
  • Dental elevator sinus lift :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental torque wrench :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Screw endosteal dental implant two-piece :
Neocare UK LtdKatswell Grange Joyford

Coleford
Gloucestershire GL16 7AR

United Kingdom







04/08/20225018
  • Cleaner/ Washer for medical devices :
  • ,
  • Endoscopes/Endoscopic Instruments And Accessories :
Neochord Inc5402 Parkdale Drive Suite 160 St Louis Park

Minneapolis
Minnesota 55416

United States

Dot Medical LtdUK Responsible PersonSilk Point Queens Avenue

Macclesfield
Cheshire SK10 2BB
UK Responsible Person
England United Kingdom
10/11/202118144
  • Chordae tendinae prosthesis implantation tool :
NeoCoil LLCN27 W23910A Paul Rd

Pewaukee
Wisconsin 53072

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/13/202221249
  • MRI image enhancement padding :
  • ,
  • MRI system coil radio-frequency :
  • ,
  • Patient audiovisual communication/entertainment system :
  • ,
  • MRI-oriented needle guide positioner :
NeoDynamics ABLejonvagen 14 SE-181 32

Stockholm
Lidingo SE-181 32

Sweden

MediLife LtdUK Responsible Person1 Manor Farm Barns School Lane
Lt.Melton
Norwich
NR9 3AE
UK Responsible Person
England United Kingdom
06/14/202224875
  • Biopsy gun handpiece :
NEOFECT Co. Ltd.#801 42
Changeop-Ro Sujeong-Gu
Gyeonggi-Do
Seongnam-Si 13449

South Korea

Baffin Technology Systems LtdUK Responsible PersonBragborough Hall Business Centre Welton Road

Braunston
NN11 7JG
UK Responsible Person
England United Kingdom
01/21/202221643
  • Virtual-display rehabilitation system non-supportive clinical :
  • ,
  • Elbow/wrist/hand orthosis :
  • ,
  • Hand orthosis :
  • ,
  • Ankle/foot orthosis :
Neogen Europe Limited1 Quest Park Moss Hall Road
Heywood
Lancashire
BL97JJ

United Kingdom







09/05/20199026
  • Differential/selective agar culture medium IVD :
  • ,
  • Culture medium antimicrobial supplement IVD :
Neomedic LtdUnit 2 Leavesden Lodge 1A Leavesden Road

Watford
Hertfordshire WD24 5FR

United Kingdom







04/17/20157089
  • Surgical/medical face mask single-use :
  • ,
  • Umbilical cord clamp single-use :
  • ,
  • Evacuated blood collection tube IVD K2EDTA :
  • ,
  • Evacuated blood collection tube IVD K3EDTA :
  • ,
  • Evacuated blood collection tube IVD sodium citrate :
  • ,
  • Evacuated erythrocyte sedimentation rate (ESR) tube IVD :
  • ,
  • Evacuated blood collection tube IVD clot activator/separator :
  • ,
  • Evacuated blood collection tube IVD anticoagulant :
  • ,
  • Evacuated blood collection tube IVD lithium heparin :
  • ,
  • Evacuated blood collection tube IVD antiglycolytic :
  • ,
  • Evacuated blood collection tube IVD anticoagulant/antiglycolytic :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Nitrile examination/treatment glove powdered :
  • ,
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Vinyl examination/treatment glove powdered :
  • ,
  • Antiseptic swab :
  • ,
  • General-purpose medical fibre padding :
  • ,
  • Assistive hat/cap :
  • ,
  • Shoe cover :
  • ,
  • Dressing-fixation skin adhesive tape non-silicone :
  • ,
  • Dressing-fixation skin adhesive tape non-silicone :
  • ,
  • Hevea-latex examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Hevea-latex examination/treatment glove powdered :
  • ,
  • Cast construction material :
  • ,
  • Cotton wool roll non-sterile :
  • ,
  • Cotton wool roll non-sterile :
  • ,
  • Cotton wool roll non-sterile :
  • ,
  • Cotton wool roll non-sterile :
  • ,
  • First aid absorbent pad/bandage :
  • ,
  • Pressure bandage non-latex reusable :
  • ,
  • Woven gauze roll non-sterile :
  • ,
  • Blood transfusion set non-exchange :
  • ,
  • Blood/tissue storage/culture container :
  • ,
  • General-purpose syringe/needle :
  • ,
  • Hevea-latex surgical glove non-powdered non-antimicrobial :
  • ,
  • Waterproof skin adhesive tape :
  • ,
  • Synthetic polymer semi-permeable film dressing adhesive :
  • ,
  • Scalp vein intravenous administration set :
  • ,
  • Scalp vein intravenous administration set :
  • ,
  • Petrolatum woven gauze pad sterile :
  • ,
  • Peripheral vascular intervention infusion catheter :
  • ,
  • Peripheral intravenous cannula :
  • ,
  • Non-woven gauze pad :
  • ,
  • Non-wearable adult urine collection bag closed-ended :
  • ,
  • Nasogastric/orogastric tube :
  • ,
  • Nasogastric feeding tube :
  • ,
  • Metered-delivery hypodermic syringe/needle :
  • ,
  • Hypodermic-needle single-use :
  • ,
  • Hypodermic-needle single-use :
  • ,
  • Indwelling urethral drainage balloon catheter non-antimicrobial :
  • ,
  • Hevea-latex surgical glove powdered :
NeoMedica dooBulevar Svetog Cara Konstantina 82-86

Nis
18103

Serbia

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
11/26/202011006
  • SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Enzyme immunoassay (EIA) analyser IVD automated :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Androstenedione IVD kit enzyme immunoassay (EIA) :
  • ,
  • Estradiol (oestradiol) (E2) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free estriol (oestriol) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Progesterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • 17-Hydroxyprogesterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Sex hormone binding globulin (SHBG) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total testosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Free testosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dehydroepiandrosterone (DHEA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Estrone (oestrone) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Anti-Mullerian hormone (AMH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Luteinizing hormone (LH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Prolactin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroglobulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroglobulin antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Parathyroid hormone (PTH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA) :
  • ,
  • Soluble transferrin receptor IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ferritin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Human growth hormone (HGH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Allergen-specific immunoglobulin E (IgE) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Insulin IVD kit enzyme immunoassay (EIA) :
  • ,
  • C-peptide IVD kit enzyme immunoassay (EIA) :
  • ,
  • D-dimer IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tissue transglutaminase antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Gliadin antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Phospholipid antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Anticardiolipin antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Beta-2-glycoprotein I antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Insulin antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 125 (CA125) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 15-3 (CA15-3) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Alpha-fetoprotein (AFP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cyclic citrullinated peptide antibody (anti-CCP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Rheumatoid factor IVD kit enzyme immunoassay (EIA) :
  • ,
  • Double stranded DNA antibody (anti-dsDNA) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Smith antibody (anti-Sm) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Scleroderma-70 antibody (anti-Scl-70) IVD kit enzyme immunoassay (EIA) :
  • ,
  • U1-RNP antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Jo-1 antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Ribosomal phosphoprotein antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Histone antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Adrenocorticotropic hormone (ACTH) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Aldosterone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total cortisol IVD kit enzyme immunoassay (EIA) :
  • ,
  • Procalcitonin (PCT) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Troponin I IVD kit enzyme immunoassay (EIA) :
  • ,
  • Digoxin therapeutic drug monitoring IVD kit enzyme immunoassay (EIA) :
  • ,
  • Myoglobin IVD kit enzyme immunoassay (EIA) :
  • ,
  • C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Carcinoembryonic antigen (CEA) IVD control :
  • ,
  • Total cortisol IVD control :
  • ,
  • C-peptide IVD control :
  • ,
  • Dehydroepiandrosterone (DHEA) IVD control :
  • ,
  • Dehydroepiandrosterone sulfate (DHEAS) IVD control :
  • ,
  • Estradiol (oestradiol) (E2) IVD control :
  • ,
  • Free estriol (oestriol) IVD control :
  • ,
  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD control :
  • ,
  • Human growth hormone (HGH) IVD control :
  • ,
  • Allergen-specific immunoglobulin E (IgE) antibody IVD control :
  • ,
  • Insulin IVD control :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD control :
  • ,
  • Luteinizing hormone (LH) IVD control :
  • ,
  • Prolactin IVD control :
  • ,
  • Progesterone IVD control :
  • ,
  • Sex hormone binding globulin (SHBG) IVD control :
  • ,
  • Total triiodothyronine (TT3) IVD control :
  • ,
  • Free triiodothyronine (FT3) IVD control :
  • ,
  • Thyroid uptake (T-uptake) IVD control :
  • ,
  • Total thyroxine (TT4) IVD control :
  • ,
  • Free thyroxine (FT4) IVD control :
  • ,
  • Total testosterone IVD control :
  • ,
  • Free testosterone IVD control :
  • ,
  • Thyroid stimulating hormone (TSH) IVD control :
  • ,
  • Vitamin B12 IVD control :
  • ,
  • 17-Hydroxyprogesterone IVD control :
  • ,
  • Ferritin IVD control :
  • ,
  • Folate (vitamin B9) IVD control :
  • ,
  • Digoxin therapeutic drug monitoring IVD control :
  • ,
  • Total prostate specific antigen (tPSA) IVD control :
  • ,
  • Free (unbound) prostate specific antigen (fPSA) IVD control :
  • ,
  • Thyroxine binding globulin (TBG) IVD control :
  • ,
  • Alpha-fetoprotein (AFP) IVD control :
  • ,
  • Thyroglobulin IVD control :
  • ,
  • Cancer antigen 15-3 (CA15-3) IVD control :
  • ,
  • Cancer antigen 19-9 (CA19-9) IVD control :
  • ,
  • Cancer antigen 125 (CA125) IVD control :
  • ,
  • Anti-Mullerian hormone (AMH) IVD control :
  • ,
  • Anti-Mullerian hormone (AMH) IVD calibrator :
  • ,
  • Aldosterone IVD calibrator :
  • ,
  • Aldosterone IVD control :
  • ,
  • Parathyroid hormone (PTH) IVD calibrator :
  • ,
  • Insulin IVD calibrator :
  • ,
  • Calcitonin IVD calibrator :
  • ,
  • Calcitonin IVD control :
  • ,
  • C-peptide IVD calibrator :
  • ,
  • Adrenocorticotropic hormone (ACTH) IVD calibrator :
  • ,
  • Adrenocorticotropic hormone (ACTH) IVD control :
  • ,
  • Multiple thyroid antibody IVD control :
  • ,
  • Myoglobin IVD control :
  • ,
  • Myoglobin IVD calibrator :
  • ,
  • Procalcitonin (PCT) IVD calibrator :
  • ,
  • Procalcitonin (PCT) IVD control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD calibrator :
  • ,
  • Troponin I IVD calibrator :
  • ,
  • Troponin I IVD control :
  • ,
  • Immunoglobulin removal reagent IVD :
  • ,
  • Adenovirus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Adenovirus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza A virus immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza A virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza A virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza B virus immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza B virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Influenza B virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple human parainfluenza virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tick-borne encephalitis (TBE) virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple enterovirus immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple enterovirus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Measles virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Measles virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mumps virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mumps virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coxsackie B virus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Toxocara canis immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Candida albicans immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Candida albicans immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Aspergillus fumigatus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Bordetella pertussis immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Bordetella pertussis immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia afzelii immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia afzelii immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia garinii immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia garinii immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Brucella species immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Treponema pallidum immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Treponema pallidum immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Yersinia enterocolitica immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Yersinia enterocolitica immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Haematological cell analyser IVD automated :
  • ,
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Blood cell lysis reagent IVD :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Multiple Campylobacter species antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Clostridium difficile antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Helicobacter pylori antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Trisomy 21-risk hormone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Vitamin B12 IVD reagent :
  • ,
  • Folate (vitamin B9) IVD reagent :
  • ,
  • Helicobacter pylori total antibody IVD control :
  • ,
  • Centromere protein antibody (anti-CENP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Erythropoietin (EPO) IVD control :
  • ,
  • Inhibin B IVD calibrator :
  • ,
  • Inhibin B IVD control :
  • ,
  • Inhibin A IVD calibrator :
  • ,
  • Inhibin A IVD control :
  • ,
  • Chromogranin A IVD calibrator :
  • ,
  • Chromogranin A IVD control :
  • ,
  • Glutamic acid decarboxylase antibody (anti-GAD) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyrosin phosphatase antibody (anti-IA2) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Adiponectin IVD control :
  • ,
  • Adiponectin IVD calibrator :
  • ,
  • Leptin IVD control :
  • ,
  • Erythropoietin (EPO) IVD calibrator :
  • ,
  • Haptoglobin IVD calibrator :
  • ,
  • Haptoglobin IVD control :
  • ,
  • Iron IVD calibrator :
  • ,
  • Iron IVD control :
  • ,
  • Renin IVD calibrator :
  • ,
  • Renin IVD control :
  • ,
  • Leptin IVD calibrator :
  • ,
  • Zinc transporter (ZnT) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Thyroid stimulating hormone receptor (TSHR) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Inhibin B IVD kit enzyme immunoassay (EIA) :
  • ,
  • Renin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Leptin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Squamous cell carcinoma antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Neuron-specific enolase (NSE) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cytokeratin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cancer antigen 72-4 (CA72-4) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Human epididymis protein 4 (HE4) IVD reagent :
  • ,
  • Cancer antigen 242 (CA242) IVD reagent :
  • ,
  • Erythropoietin (EPO) IVD reagent :
  • ,
  • Chromogranin A IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepcidin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Inhibin A IVD kit enzyme immunoassay (EIA) :
  • ,
  • Listeria monocytogenes immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Sperm antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Interleukin-6 (IL-6) IVD reagent :
  • ,
  • Haptoglobin IVD antibody :
  • ,
  • Calprotectin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Adiponectin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Neopterin IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple antinuclear antibody (ANA) screening IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 neutralizing antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD control :
  • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD control :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD calibrator :
  • ,
  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD calibrator :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
NeoMedLight88-90 Rue Frederic Fays

Villeurbanne
Lyon 69100

France

Oncology Imaging Systems LtdUK Responsible PersonCarriers Way East Hoathly

Lewes
East Sussex BN8 6AG
UK Responsible Person
England United Kingdom
08/03/202116481
  • Blanket/pad infant phototherapy unit :
  • ,
  • Red-light phototherapy unit :
  • ,
  • Medical equipment drape single-use :
Neomend60
Technology Dr Irvine
Orange
CA 92618

United States

Becton Dickinson U.K. LimitedUK Responsible Person1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS
UK Responsible Person
England United Kingdom
02/16/202112167
  • Surgical internal adhesive/sealant microbe-derived :
  • ,
  • General-purpose absorbent tip applicator/swab single-use :
Neorad B.V.Laan van Brabant 30

Roosendaal
4701 BK

Netherlands

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
12/24/202120890
  • Laser patient positioning system :
Neos Surgery S.L.C/ Ceramistes 2 Cerdanyola del Valles (Barcelona)

Barcelona
08290

Spain

Joint Operations (UK) LLPUK Responsible Person21 Broadwalk Pinner Road

North Harrow
HA2 6ED
UK Responsible Person
England United Kingdom
06/18/202115326
  • Cranial bone flap fixation clip :
NeoSoft LLCN27 W23910A Paul Road,,

Pewaukee
Wisconsin 53072,

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/07/202118102
  • MRI system application software :
  • ,
  • Radiology picture archiving and communication system digital archive device :
Neoss ABArvid Wallgrens backe 20

Göteborg
SE 41346

Sweden

Neoss LtdUK Responsible PersonWindsor House Cornwall Road

Harrogate
HG1 2PW
UK Responsible Person
United Kingdom
04/12/202214067
  • Surgical drill guide reusable :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Bone tack inserter basic :
  • ,
  • Dental precision attachment fitting/adjustment tool :
  • ,
  • Dental implantation drilling template guide-sleeve :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Membrane fixation tack non-bioabsorbable :
  • ,
  • Pliable-polymer dental regeneration membrane non-bioabsorbable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental instrument depth limiter :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Manual bone mill :
  • ,
  • Instrument tray reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical mallet :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical screwdriver reusable :
Neoss LtdWindsor House Cornwall Road

Harrogate
HG1 2PW

United Kingdom







04/10/20226847
  • Pliable-polymer dental regeneration membrane bioabsorbable tacked :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental implant/prosthesis surgical procedure kit :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Surgical drill guide single-use non-sterile :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Bone tap reusable :
  • ,
  • Manual bone mill :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Surgical countersink reusable :
  • ,
  • Pliable-polymer dental regeneration membrane bioabsorbable tacked :
  • ,
  • Instrument tray reusable :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental implant suprastructure permanent preformed :
Neosteo1 Boulevard Jean Moulin

Nantes
44100

France

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
04/14/202215530
  • Orthopaedic bone staple non-adjustable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic bone staple non-adjustable non-sterile :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Orthopaedic bur single-use :
  • ,
  • Manual orthopaedic bender single-use :
  • ,
  • Instrument tray reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Bone approximation clamp :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Surgical instrument/implant rack :
  • ,
  • Surgical implant template reusable :
  • ,
  • Orthopaedic implant aiming arm :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Orthopaedic bone-fragment manipulator reusable :
  • ,
  • Orthopaedic surgical distractor internal :
Neotech Products LLC28430 Witherspoon Pkwy

Valencia
California 91355

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/23/202223211
  • Pressure bandage non-latex single-use :
  • ,
  • Dressing-fixation skin adhesive tape non-silicone :
  • ,
  • Personal device holder single-use :
  • ,
  • Nasal oxygen cannula basic :
  • ,
  • Endotracheal tube holder :
  • ,
  • Wearable percutaneous catheter/tube holder :
  • ,
  • Airway suction catheter :
  • ,
  • Neonatal electrocardiographic electrode :
  • ,
  • Cable/lead holder :
  • ,
  • Dressing-fixation skin adhesive tape silicone :
  • ,
  • Frame/rail/pole device holder :
  • ,
  • Tracheostomy tube neck holder single-use :
  • ,
  • Patient tube cushion :
  • ,
  • Eye mask :
Neoteryx LLC Inc.421 AMAPOLA AVE

TORRANCE
California 90501-1423

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/20/202120184
  • Biological fluid specimen collection cartridge IVD :
NeoTract Inc.4155 Hopyard Road

Pleasanton
California 94588

United States

TFX Group Ltd (T/A Teleflex Medical UK)UK Responsible PersonGrosvenor House Horseshoe Crescent

Old Town Beaconsfield
Buckinghamshire HP9 1LJ
UK Responsible Person
England United Kingdom
03/30/202113065
  • Prostatic retraction implant :
Neovasc Inc.13700 Mayfield Place Unit 2135

Richmond
V6V 2E4

Canada

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/03/202114351
  • Bare-metal coronary artery stent :
Neoventa Medical ABNorra Ågatan 32

Mölndal
43135

Sweden

Neoventa Medical Ltd UK Responsible Person34 Anyards Road

Cobham
Surrey KT 11 2LA
UK Responsible Person
England United Kingdom
regulatory@neoventa.com
11/05/202119846
  • Electrocardiographic lead set reusable :
NEPESMOTC Group Level 1 Devonshire House
One Mayfair Place
London
W1J 8AJ

United Kingdom







07/23/20198853
  • Laboratory instrument/analyser application software IVD :
nerbe plus GmbH & Co KGPorschestrasse 25

Winsen / Luhe
21423

Germany

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
08/10/202116702
  • General-purpose absorbent tip applicator/swab single-use :
  • ,
  • Cell culture medium IVD :
  • ,
  • Pipette tip IVD :
  • ,
  • General specimen container IVD no additive/medium :
  • ,
  • Non-woven gauze pad non-sterile :
Nero Dental Studio2nd Floor 18 - 20 The Rock Bury

Greater Manchester
BL9 0NT

England United Kingdom







01/22/202111722
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Ceramic dental inlay :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Preformed dental crown temporary :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Dental cusp permanent :
  • ,
  • Dental cusp temporary :
  • ,
  • Denture reliner hard :
  • ,
  • Denture reliner soft professional :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Dental veneer professional :
  • ,
  • Preformed complete denture :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental occlusal splint preformed single-use :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Custom-made mouthguard :
Nervecentre Software Ltd18 Market Place

Wokingham
Berkshire RG40 1AL

United Kingdom







09/14/20155280
  • Administrative risk-management information system application software :
Ness Art Dental Laboratory18 Redcastle View

Kirkhill
Ivernesshire IV5 7NN

United Kingdom







03/08/20198578
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Denture reliner hard :
  • ,
  • Denture reliner soft home-use :
  • ,
  • Denture reliner soft professional :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Teeth whitening tray :
  • ,
  • Custom-made mouthguard :
  • ,
  • Orthodontic retainer :
  • ,
  • Bite registration rim wax plate :
Netop Industrial Company LimitedDapu Industrial Zone Gangzi Village Changping Town

Dongguan City Guangdong
523571

China
+86(769)83999008
sh_wang@netop.com.hk
Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
06/21/202211004
  • Nasal phototherapy system :
  • ,
  • Otoscope direct :
  • ,
  • Nasal phototherapy system :
  • ,
  • Red/blue light phototherapy unit :
  • ,
  • Analgesic transcutaneous electrical nerve stimulation system :
  • ,
  • Perineal orifice incontinence-control electrical stimulator home-use :
  • ,
  • Infrared patient thermometer ear/skin :
  • ,
  • Infrared patient thermometer ear :
  • ,
  • Infrared patient thermometer skin :
  • ,
  • Nasal phototherapy system :
  • ,
  • Urinary-incontinence vaginal insert reusable :
Netop Industrial Company LimitedDapu Industrial Zone Gangzi Village Changping Town

Dongguan City Guangdong Province
523571

China

Wellkang LtdUK Responsible Person16 Castle St.

Dover
Kent CT16 1PW
UK Responsible Person
England United Kingdom
09/03/202117266
  • Analgesic transcutaneous electrical nerve stimulation system :
  • ,
  • Nasal phototherapy system :
Network Medical Products Ltd.Coronet House Kearsley Road

Ripon
North Yorkshire HG4 2SG

United Kingdom







11/26/20199326
  • Ophthalmic implant handling forceps reusable :
  • ,
  • Lacrimal intubation set :
  • ,
  • Lacrimal intubation set :
  • ,
  • Corneal resection holder single-use :
  • ,
  • Keratome blade single-use :
  • ,
  • Nasal haemostatic balloon :
  • ,
  • Donor cornea delivery set :
  • ,
  • Medical device cleaning sponge/set :
  • ,
  • Ear wick non-biodegradable :
  • ,
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Intranasal splint non-biodegradable :
  • ,
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Corneal trephine single-use :
  • ,
  • Medical device cleaning sponge/set :
  • ,
  • Headband single-use :
  • ,
  • Ophthalmic sponge :
  • ,
  • Ophthalmic sponge :
  • ,
  • Tympanostomy tube :
  • ,
  • Corneal punch set :
  • ,
  • Corneal punch set :
Neubourg Pharma (UK) Ltd75 Springfield Road

Chelmsford
Essex CM2 6JB

England United Kingdom







10/07/202119149
  • Skin moisture barrier dressing :
NeuMoDx Molecular1250 Eisenhower Pl Ann Arbor

Washtenaw
MI 48108-3281

United States

QIAGEN Manchester Ltd.UK Responsible PersonQIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH
UK Responsible Person
England United Kingdom
03/31/202213041
  • Cytomegalovirus (CMV) nucleic acid IVD control :
  • ,
  • Cytomegalovirus (CMV) nucleic acid IVD calibrator :
  • ,
  • Cytomegalovirus (CMV) nucleic acid IVD reagent :
  • ,
  • Molecular grade lysis reagent IVD :
  • ,
  • Assay development analyte-specific reagent IVD :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
  • ,
  • Microplate IVD :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD reagent :
  • ,
  • Human papillomavirus (HPV) nucleic acid IVD reagent :
  • ,
  • Beta-haemolytic Group B Streptococcus nucleic acid IVD reagent :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Oral/upper respiratory tract specimen collection kit IVD clinical :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Molecular grade buffered sample diluent IVD :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD reagent :
  • ,
  • Hepatitis B virus nucleic acid IVD calibrator :
  • ,
  • Hepatitis B virus nucleic acid IVD control :
  • ,
  • Hepatitis B virus nucleic acid IVD reagent :
  • ,
  • Hepatitis C virus nucleic acid IVD calibrator :
  • ,
  • Hepatitis C virus nucleic acid IVD control :
  • ,
  • Hepatitis C virus nucleic acid IVD reagent :
  • ,
  • HIV1 nucleic acid IVD calibrator :
  • ,
  • HIV1 nucleic acid IVD control :
  • ,
  • HIV1 nucleic acid IVD reagent :
  • ,
  • Laboratory waste receptacle IVD :
  • ,
  • Molecular grade lysis reagent IVD :
  • ,
  • Buffered wash solution IVD automated/semi-automated system :
  • ,
  • Molecular grade buffered sample diluent IVD :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
  • ,
  • Laboratory waste receptacle IVD :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Assay development analyte-specific reagent IVD :
  • ,
  • Microplate IVD :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD reagent :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD calibrator :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD control :
  • ,
  • Multiple respiratory virus nucleic acid IVD reagent :
  • ,
  • Multiple respiratory virus nucleic acid IVD control :
NEURAVI LIMITEDBLOCK 3 BALLYBRIT BUSINESS PARK

GALWAY
CONNAUGHT H91 K5YD

Ireland

Johnson & Johnson Medical LtdUK Responsible PersonBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP
UK Responsible Person
Scotland United Kingdom
01/18/202111614
  • Thrombectomy suction catheter :
Neuro Event Labs UK LimitedLygon House 50 London Road

Bromley
Kent BR1 3RA

England United Kingdom







11/17/202120200
  • Home seizure monitoring system :
Neuroelectrics Barcelona S.L.UAvda. Tibidabo 47 bis

Barcelona
8035

Spain

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/22/202121395
  • Electroencephalographic monitoring system portable :
Neuromedex GmbHVierenkamp 15

Hamburg
22453

Germany

Delta Surgical LimitedUK Responsible PersonUnit 10 Evolution Lymedale Business Park

Newcastle under Lyme
Staffordshire ST5 9QF
UK Responsible Person
United Kingdom
05/04/202114389
  • Surgical vessel loop :
  • ,
  • Surgical tissue/fluid collection bag sterile :
  • ,
  • Brain biopsy procedure kit :
  • ,
  • Luer connector kit :
  • ,
  • Cerebrospinal fluid external drainage kit :
  • ,
  • Intracerebral infusion/drainage catheter short-term : Intracerebral infusion/drainage catheter short-term Conformity Assessment Certificate Expired
Neuromod Devices LimitedRainsford Street

Dublin
D08 R2YP

Ireland

Compliant Medical Devices LtdUK Responsible PersonThe Chapel

Whitchurch
Hampshire RG28 7LN
UK Responsible Person
England United Kingdom
10/26/202118558
  • Tinnitus therapy auditory/translingual electrical stimulation system :
Neuronostics LimitedEngine Shed Station Approach

Bristol
BS1 6QH

England United Kingdom







04/23/202113761
  • Bioelectrical signal analysis software :
NeuroResponse CIC2 Adelaide Crescent Flat 4

Brighton And Hove
BN3 2JD

England United Kingdom







05/09/202224567
  • Clinical management support software :
Neurorestorative and Neurorehabilitation Solutions Pvt Ltd71 -75 Shelton Street Covent Gardens

London
London WC2H 9JQ

England United Kingdom







04/14/20229812
  • Visuomotor stimulation neuromuscular rehabilitation software :
Neurosoft LLC5 Voronin Str.

Ivanovo
153032

Russia

Dantec Dynamics LtdUK Responsible Person3rd Floor 1 Ashley Road

Altrincham
Cheshire WA14 2DT
UK Responsible Person
England United Kingdom
11/07/202118970
  • Electromyograph :
  • ,
  • Neurophysiologic monitoring system :
Neurotheraputics at University College LondonAlexandra House 17 Queen Square

London
WC1N 3AZ

United Kingdom







02/13/20198037
  • Cognitive training software :
NeuroVasc Technologies Inc.3 Jenner Ste. 100

Irvine
California 92618

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
08/26/202117069
  • Thrombectomy suction catheter :
  • ,
  • Vascular guide-catheter single-use :
  • ,
  • Thrombectomy suction catheter :
NEUWAVE MEDICAL INC3529 ANDERSON STREET

MADISON
Wisconsin 53704

United States

Johnson & Johnson Medical LtdUK Responsible PersonBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP
UK Responsible Person
Scotland United Kingdom
01/08/202111459
  • Microwave ablation system probe :
  • ,
  • Medical device service rail :
  • ,
  • Surgical instrument assist arm system manually-adjusted :
Nevro Corporation1800 Bridge Parkway

Redwood City CA
94065

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
07/13/202115541
  • Implant battery charger :
  • ,
  • Epidural needle non-threaded :
  • ,
  • Implantable pulse generator port plug :
  • ,
  • Medical ruler reusable :
  • ,
  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator implantable :
  • ,
  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension :
  • ,
  • Electrosurgical cable adaptor :
  • ,
  • Neurosurgical procedure kit non-medicated single-use :
  • ,
  • Neural-tissue electrical stimulation lead adaptor :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Vascular graft tunneller :
  • ,
  • Soft-tissue/mesh anchor non-bioabsorbable :
  • ,
  • Central nervous system electrical stimulation system lead stylet :
  • ,
  • Surgical implant/trial-implant/sizer holder single-use :
  • ,
  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead wired connection :
  • ,
  • Personal device holder reusable :
  • ,
  • Implantable spinal cord electrical stimulation system programmer :
  • ,
  • Active implantable device control magnet :
  • ,
  • Rechargeable battery pack :
  • ,
  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator :
New Ancorvis SrlVia dell'Industria 15 Bargellino

Bologna
40012

Italy

Donawa Lifescience LtdUK Responsible PersonAviation Business Park Enterprise Close

Christchurch
BH23 6NX
UK Responsible Person
England United Kingdom
04/30/202114257
  • Resilient dental precision attachment :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental prosthesis/implant abutment screw analog reusable :
  • ,
  • Surgical torque wrench adaptor :
  • ,
  • Dental precision attachment fitting/adjustment tool :
  • ,
  • Dental implantation drilling template custom-made :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental prosthesis/implant abutment screw :
New Co-ordinates Limited t/a Newco SurgicalUnit J15 Hastingwood Industrial Park
Wood Lane Erdington
Birmingham
West Midlands B24 9QR

United Kingdom







06/21/20046717
  • Surgical Instruments (Re-Usable And Non-Powered) :
  • ,
  • Dental Instruments (Re-Usable & Non-Powered) :
  • ,
  • Handheld Dental Mirrors And Accessories :
  • ,
  • Pre-Operative Devices (Razor/Marker Pen) :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Dressing/utility forceps scissors-like reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • Surgical soft-tissue manipulation forceps alligator reusable :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Suction cannula reusable :
  • ,
  • Open-surgery biopsy forceps reusable :
  • ,
  • Surgical mallet :
  • ,
  • Towel clamp reusable :
  • ,
  • Urethral dilator reusable :
  • ,
  • Dressing/utility forceps tweezers-like reusable :
  • ,
  • Vaginal dilator :
  • ,
  • Vaginal speculum reusable :
  • ,
  • General-purpose curette :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Open-surgery dissector :
  • ,
  • Orthopaedic chisel :
  • ,
  • Orthopaedic knife :
  • ,
  • Adenoid curette reusable :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Bone raspatory :
  • ,
  • Cast cutting shears :
  • ,
  • Cast spreader :
  • ,
  • Common bile duct dilator :
  • ,
  • Dental anaesthesia syringe reusable :
  • ,
  • Dental excavator reusable :
  • ,
  • Dental irrigation/aspiration syringe :
  • ,
  • Dental mirror reusable :
  • ,
  • Ear knife :
  • ,
  • Airway tube forceps reusable :
  • ,
  • Ear speculum reusable :
  • ,
  • ENT elevator :
  • ,
  • ENT punch :
  • ,
  • Gallstone scoop :
  • ,
  • Gastro-urological director :
  • ,
  • Gastro-urological probe :
  • ,
  • General/plastic surgery mirror :
  • ,
  • Gynaecological biopsy forceps reusable :
  • ,
  • Intrauterine cannula reusable :
  • ,
  • Endaural surgical curette reusable :
  • ,
  • Hand-held dental retractor :
  • ,
  • Intraocular scissors conventional-hinge reusable :
  • ,
  • Lacrimal dilator reusable :
  • ,
  • Laryngeal mirror reusable :
  • ,
  • Open-surgery ligation clip applier :
  • ,
  • Manual surgical saw blade flexible reusable :
  • ,
  • Meniscus knife :
  • ,
  • Middle ear malleus nipper :
  • ,
  • Mouth gag non-adjustable :
  • ,
  • Mouth gag adjustable reusable :
  • ,
  • Myoma screw reusable :
  • ,
  • Bone awl reusable :
  • ,
  • Nail clippers reusable :
  • ,
  • Nasal knife :
  • ,
  • Nasal saw :
  • ,
  • Nasal scissors :
  • ,
  • Nasal snare reusable :
  • ,
  • Nasal speculum reusable :
  • ,
  • Obstetrical forceps reusable :
  • ,
  • Periosteal elevator reusable :
  • ,
  • Rectal dilator reusable :
  • ,
  • Rectal speculum :
  • ,
  • Bone curette reusable :
  • ,
  • Ring cutter :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Scalpel handle reusable :
  • ,
  • Skin marking pen reusable :
  • ,
  • Skin/tissue hook :
  • ,
  • Surgical bulldog clamp reusable :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Surgical gouge :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Bone cutting forceps :
  • ,
  • Soft-tissue surgical hook reusable :
  • ,
  • Tongue depressor surgical :
  • ,
  • Tonsil snare :
  • ,
  • Tooth extraction forceps :
  • ,
  • Urethral sound reusable :
  • ,
  • Wire cutter :
  • ,
  • Wire/ligature passer reusable :
  • ,
  • Uterine tenaculum :
  • ,
  • Instrument tray reusable :
  • ,
  • Bone holding forceps :
  • ,
  • Bone hook :
  • ,
  • Bone lever/elevator reusable :
New Erie Scientific LLC (a subsidiary of Epredia)20 Post Road

Portsmouth
NH 03801

United States

Shandon Diagnostics Limited a subsidiary of EprediaUK Responsible PersonTudor Road Manor Park

Runcorn
Cheshire WA7 1TA
UK Responsible Person
United Kingdom
04/12/202113268
  • Microscope slide coverslip IVD :
  • ,
  • General specimen microscopy slide IVD single-use :
New Look Ortholabs Ltd2C Park Lane

Hornchurch
Essex RM11 1BB

United Kingdom







04/07/20224627
  • Dental Appliances/Prostheses :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic habit prevention/breaking appliance bonded :
  • ,
  • Custom-made mouthguard :
  • ,
  • Orthodontic anchor plate :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic palate expander screw self-removable :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Dental occlusal splint preformed single-use :
NEW MEDIC Co. Ltd.#701 #702 #703 #704 #708 #713 O'BIZ TOWER 126 Beolmal-ro Dongan-gu
Anyang-si
Gyeonggi-do
10285

South Korea

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
04/14/202221253
  • Dermal tissue reconstructive material microbe-derived anaesthetic :
New Pelvic Pain Technologies Inc.548 Market Street Suite 88577

San Francisco
California 94104

United States

AJW Technology Consulting LtdUK Responsible Person4/4a Bloomsbury Square

London
WC1A 2RP
UK Responsible Person
England United Kingdom
04/13/202221922
  • External manual massager clinical :
  • ,
  • Hand-held electric massager :
New Smile Lab ltd13A Peacock Yard Iliffe Street

London
SE17 3LH

United Kingdom







08/05/20155260
  • Dental Appliances/Prostheses :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Dental veneer professional :
  • ,
  • Bonded dental bridge :
  • ,
  • Dental implant abutment analog laboratory :
NEW WELLNESS CONCEPTNº 25 floor 8º S.L. Avenida República Argentina

Seville
CP41011

Spain

iMEDicare LTDUK Responsible Person27 Rosemary Drive

St. Albans
Hertfordshire AL2 1UD
UK Responsible Person
England United Kingdom
darren@imedicare.co.uk
06/13/202224821
  • Mindfulness/behavioural therapy software clinician-consultative :
New World Medical10763 Edison Court

Rancho Cucamonga
California 91370

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
04/30/202114210
  • Glaucoma shunt :
  • ,
  • Ophthalmic knife single-use :
  • ,
  • Eye valve :
Newbury Dental Laboratories LtdUnit 15B Kingfisher Court

Newbury
Berkshire RG14 5SJ

United Kingdom







04/06/20223299
  • Dental Appliances/Prostheses :
Newclip Technics45 rue des Garottières PA de la lande ST martin

Haute goulaine
Haute goulaine 44115

France

NEWCLIP TECHNICS UK LTDUK Responsible PersonWilberforce House Station Road

LONDON
NW4 4QE
UK Responsible Person
England United Kingdom
04/30/202114296
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
  • ,
  • Orthopaedic bone washer non-sterile :
  • ,
  • Orthopaedic bone washer sterile :
  • ,
  • Surgical countersink reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Orthopaedic surgical procedure kit non-medicated single-use :
  • ,
  • Scalpel single-use :
  • ,
  • Orthopaedic implant/instrument adaptor reusable :
  • ,
  • Surgical screwdriver single-use sterile :
  • ,
  • Surgical depth gauge single-use :
  • ,
  • Surgical implant template single-use :
  • ,
  • Surgical countersink single-use :
  • ,
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable sterile :
  • ,
  • Interphalangeal joint arthrodesis implant :
  • ,
  • Orthopaedic chisel :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Surgical countersink reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Wire cutter :
  • ,
  • Surgical implant template reusable :
  • ,
  • Bone distraction forceps :
  • ,
  • Surgical drill guide reusable :
  • ,
  • General internal orthopaedic fixation system implantation kit :
  • ,
  • Manual orthopaedic bender reusable :
  • ,
  • Bone holding forceps :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Surgical instrument handle torque-limiting :
  • ,
  • Orthopaedic implantation sleeve reusable :
  • ,
  • Orthopaedic bone pin container :
  • ,
  • Osteotomy guide reusable :
  • ,
  • Custom-made organ/bone anatomy model/surgical guide kit :
  • ,
  • Instrument tray reusable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
Newdeal SASImmeuble Séquoïa 2 97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
Saint Priest
69800

France

T.J.Smith and Nephew LimitedUK Responsible Person101 Hessle Road

Hull
HU3 2BN
UK Responsible Person
England United Kingdom
04/27/202214608
  • Sterilization/disinfection container reusable :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Cannulated surgical drill bit single-use sterile :
  • ,
  • Orthopaedic bone washer non-sterile :
  • ,
  • Orthopaedic bone washer sterile :
  • ,
  • Interphalangeal joint arthrodesis implant :
  • ,
  • Bone nail guidewire single-use :
  • ,
  • Orthopaedic bone staple non-adjustable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Wire/ligature passer reusable :
  • ,
  • Wire/ligature passer reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Bone-resection orthopaedic reamer reusable :
  • ,
  • Orthopaedic bur single-use :
  • ,
  • Orthopaedic bur single-use :
  • ,
  • Surgical implant template reusable :
  • ,
  • Surgical implant template reusable :
  • ,
  • Surgical instrument guard single-use sterile :
  • ,
  • Bone holding forceps :
  • ,
  • Headache stick :
  • ,
  • Cannulated surgical drill bit single-use sterile :
  • ,
  • Cannulated surgical drill bit single-use sterile :
  • ,
  • Bone-resection orthopaedic reamer single-use :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic bone staple driver :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Bone awl reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Surgical depth gauge reusable :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Manual surgical rotary handpiece reusable :
  • ,
  • Bone distraction forceps :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Orthopaedic reamer guide :
  • ,
  • Surgical implant template reusable :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Surgical implant/trial-implant/sizer holder reusable :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Bone curette reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
  • ,
  • Orthopaedic bone staple non-adjustable non-sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
  • ,
  • Arthrodesis nail sterile :
  • ,
  • Bone nail end-cap :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Bone holding forceps :
  • ,
  • Cannulated surgical drill bit single-use sterile :
Newmed SRLVia Lenin 79/A

Quattro Castella (RE)
42020

Italy

Dentalex LtdUK Responsible PersonSingleton Court Business Ctr Wonastow Road West
Monmouth
Monmouth
Monmouthshire NP25 5JA
UK Responsible Person
United Kingdom
04/22/202223222
  • Steam sterilizer :
  • ,
  • Ultrasonic water bath :
Newquay Dental Lab5 Leader Road St Columb Minor

Newquay
Cornwall TR7 3HJ

United Kingdom







04/03/20221479
  • Complete lower denture :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Dental Appliances/Prostheses :
NewScen Coast Bio-Pharmaceutical Co. Ltd.No. 65 6th Street Tianjin TEDA

Tianjin
300457

China

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
04/28/202210590
  • Buffered sample diluent IVD manual :
  • ,
  • C-reactive protein (CRP) IVD kit fluorescent immunoassay :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • Procalcitonin (PCT) IVD kit rapid ICT clinical :
  • ,
  • C-reactive protein (CRP) IVD kit rapid ICT clinical :
  • ,
  • Alpha-fetoprotein (AFP) IVD kit rapid ICT clinical :
  • ,
  • Carcinoembryonic antigen (CEA) IVD kit rapid ICT clinical :
  • ,
  • Multiple cardiac marker IVD kit rapid ICT clinical :
  • ,
  • D-dimer IVD kit rapid ICT clinical :
  • ,
  • Microalbumin IVD kit rapid ICT clinical :
  • ,
  • Thyroid stimulating hormone (TSH) IVD kit rapid ICT clinical :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD reagent :
  • ,
  • Multiple anti-neutrophil cytoplasmic antibody/glomerular basement membrane antibody IVD kit fluorescent immunoassay :
  • ,
  • Follicle stimulating hormone (FSH) IVD kit rapid ICT self-testing :
  • ,
  • Ferritin IVD kit rapid ICT self-testing :
  • ,
  • Faecal occult blood IVD kit rapid ICT self-testing :
  • ,
  • HIV1 antibody IVD kit rapid ICT clinical :
  • ,
  • HIV1/HIV2 antibody IVD kit rapid ICT clinical :
  • ,
  • Hepatitis C virus total antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical :
  • ,
  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay rapid :
  • ,
  • Immunoassay reagent vehicle reader IVD :
Newyu IncSuite 352
3452 Lake Lynda Dr Orlando
Orange
FL 32817

United States

Abbott Diabetes Care LtdUK Responsible PersonRange Road

Witney
OX290YL
UK Responsible Person
England United Kingdom
02/10/202212024
  • Self-care monitoring/reporting software :
NEXA Medical LimitedSuite 5-6 Willow View Southfields Church Lane West Parley

Ferndown
Dorset BH22 8TR

United Kingdom







01/19/20165887
  • Negative-pressure wound therapy system battery-powered reusable :
  • ,
  • Negative-pressure wound therapy system dressing set :
  • ,
  • Negative-pressure wound therapy system canister :
NEXOR Medical GmbHTake-Off Gewerbepark 9

Neuhausen ob Eck
Baden-Wuerttemberg 78579

Germany

MEDAGENT INTERNATIONAL UK LIMITEDUK Responsible Person2 St Andrews Place

Lewes
East Sussex BN7 1UP
UK Responsible Person
England United Kingdom
04/15/202222513
  • Operating room light :
Nexstim PlcElimäenkatu 9 b,,,

Helsinki
510,

Finland

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
09/28/202117925
  • Stereotactic neuronavigation/planning system :
NEXT Medical Products Company LLC45 Columbia Rd. Branchburg

New Jersey
08876

United States

PENTLAND MEDICAL LTDUK Responsible Person157 Broomhall Crescent

EDINBURGH
EH12 7PJ
UK Responsible Person
Scotland United Kingdom
04/08/202222376
  • Operating table patient positioning set single-use :
Next Science LLC10550 Deerwood Park Blvd,,,

Jacksonville
Florida 32256,

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
10/07/202118125
  • Wound hydrogel dressing antimicrobial :
  • ,
  • Antimicrobial wound irrigation solution sterile :
NEXTBIOMEDICAL CO. LTD.6 Venture-ro 100beon-gil Yeonsu-gu

Incheon
22013

South Korea

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
06/22/202115470
  • Non-organic haemostatic agent :
  • ,
  • Haematological concentrate/haemostatic agent applicator cannula endoscopic single-use :
  • ,
  • Embolization particle non-bioabsorbable :
  • ,
  • Needleless medication/vaccine injector mechanical :
  • ,
  • Embolization particle non-bioabsorbable :
  • ,
  • Non-organic haemostatic agent :
Nextgen Health SolutionsKemp House 160 City Road

London
EC1V 2NX

England United Kingdom







04/11/20228133
  • Self-care monitoring/reporting software :
Nextremity Solutions Inc210 N Buffalo St

Warsaw
46580-2730

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
05/03/202114350
  • Orthopaedic surgical procedure kit non-medicated single-use :
Nexus Dental Laboratory Ltd18 Raglan Street

Harrogate
North Yorkshire HG1 1LE

United Kingdom







04/22/20154421
  • Dental Appliances/Prostheses :
  • ,
  • Orthodontic teeth positioner preformed :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Dental prosthesis/implant abutment screw analog reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental prosthesis fabrication material polymer :
  • ,
  • Dental appliance fabrication material ceramic :
  • ,
  • Dental appliance fabrication material combination-material :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental composite resin kit :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Sliding dental precision attachment :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Polymer-based dental model material :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Bite registration rim wax :
  • ,
  • Bite registration rim :
  • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
NG BiotechZ.A .Courbouton secteur 1 Atelier Relais Tremplin

Guipry-Messac
35480

France

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
02/01/202222525
  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD kit :
  • ,
  • Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid :
  • ,
  • Blood culture broth kit IVD :
NG Medical GmbhTalsperrenblick 5

Nonnweiler
66620

Germany

Osteon Medical LtdUK Responsible Person133 Tame Road Birmingham

Birmingham
B67DG
UK Responsible Person
England United Kingdom
03/19/202213964
  • Cervical total intervertebral disc prosthesis one-piece :
  • ,
  • Metallic spinal interbody fusion cage :
  • ,
  • Polymeric spinal interbody fusion cage :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Metallic spinal interbody fusion cage :
  • ,
  • Polymeric osteotomy fusion cage non-customized :
NGPOD Global Limited7 Berkeley Court

Runcorn
Cheshire WA7 1TQ

England United Kingdom







05/21/20198732
  • Nasogastric tube placement pH display unit :
  • ,
  • Nasogastric tube placement pH sensor :
  • ,
  • Gastro-oesophageal pH/impedance catheter :
NHS Digital1 Trevelyan Square
Boar Lane GBR
LEEDS
West Yorkshire LS1 6AE

United Kingdom







09/19/20188139
  • Emergency-care information system :
  • ,
  • Clinical management support software :
NHS Dumfries and GallowayCSSD Mountainhall Treatment Centre
Bankend Road Dumfries
Dumfries
Dumfriesshire DG1 4AP

Scotland United Kingdom







03/24/202223827
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Ophthalmic surgical procedure kit non-medicated reusable :
  • ,
  • Laparoscopic surgical procedure kit non-medicated reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • General surgical procedure kit non-medicated reusable :
  • ,
  • Obstetrical/gynaecological surgical procedure kit non-medicated reusable :
  • ,
  • Urological surgical procedure kit non-medicated reusable :
  • ,
  • ENT surgical procedure kit non-medicated reusable :
  • ,
  • Arthroscopic surgical procedure kit non-medicated reusable :
  • ,
  • Podiatry kit reusable :
NHS Education for Scotland102 West Port West Port

Edinburgh
Midlothian EH3 9DN

United Kingdom







07/14/20164379
  • Standalone Software :
NHS Forth ValleyOrthodontic laboratory Area 6 Forth Valley Royal Hoapital
Stirling Road
Larbert
FK5 4RW

United Kingdom







09/08/202010529
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Tongue-training sleep-disordered breathing orthosis :
  • ,
  • Custom-made dental anatomy model :
NHS Grampian/ Dental LaboratorySummerfield House 2 Eday Road

Aberdeen
Aberdeenshire AB15 6RE

United Kingdom







07/01/20144367
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Dental base plate :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Bite registration rim :
  • ,
  • Tongue-training sleep-disordered breathing orthosis :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant suprastructure temporary custom-made :
  • ,
  • Dental implantation drilling template custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Orthodontic appliance system self-removable :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic clasp metal custom-made :
  • ,
  • Orthodontic appliance positioning tray :
  • ,
  • Orthodontic appliance/positioning tray kit :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic palate expander/teeth aligner bonded :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Root canal post custom-made :
  • ,
  • Bonded dental bridge :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Resin dental inlay :
  • ,
  • Dental veneer professional :
  • ,
  • Orthodontic retainer :
  • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
  • ,
  • Dental impression tray reusable :
  • ,
  • Dental appliance/prosthesis connector :
  • ,
  • Orthodontic resin positioning tray :
  • ,
  • Palate prosthesis :
  • ,
  • Palate-lifting sleep-disordered breathing orthosis :
  • ,
  • Speech assistive training device :
  • ,
  • Tongue-training dental orthosis :
  • ,
  • Bar dental precision attachment :
NHS Greater Glasgow & ClydeMedical Devices Unit West Glasgow ACH
Dalnair Street
Glasgow
G3 8SJ

Scotland United Kingdom

ggc.mdu@nhs.scot






04/12/202224180
  • Vision testing/training chart :
NHS North of England Commissioning Support UnitJohn Snow House

Durham
DH1 3YG

England United Kingdom







08/04/202116695
  • Clinical management support software :
NHS Scotland (CDU)South Road Lerwick

Shetland
Shetland Islands ZE1 0TB

Scotland United Kingdom







04/05/20222720
  • Surgical Procedure Packs (Includes Instruments Supplied Singularly) :
  • ,
  • ENT surgical procedure kit non-medicated reusable :
  • ,
  • Urological surgical procedure kit non-medicated reusable :
  • ,
  • Ophthalmic surgical procedure kit non-medicated reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Obstetrical/gynaecological surgical procedure kit non-medicated reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Laparoscopic surgical procedure kit non-medicated reusable :
  • ,
  • General surgical procedure kit non-medicated reusable :
NHS TaysideDundee Dental Hospital 2 Park Place

DUNDEE
ANGUS DD1 4HR

United Kingdom







04/14/20209816
  • Orthodontic retainer :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental veneer professional :
  • ,
  • Ceramic dental inlay :
  • ,
  • Dental bridge polymer :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Gold dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Partial denture :
  • ,
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Speech assistive training device :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown metal/polymer :
NHSBT ReagentsNHSBT Reagents 14 Estuary Banks
Speke
Liverpool
L24 8RB

United Kingdom







10/09/20063237
  • Copper sulfate solution IVD reagent :
  • ,
  • Antibody 2 cell screening :
  • ,
  • Antibody identification cell panels :
  • ,
  • ABO grouping cells :
  • ,
  • Immunoglobulin-sensitized reagent red blood cell IVD control :
  • ,
  • Weak anti-D IVD control :
  • ,
  • Bromelin immunohaematology reagent IVD :
  • ,
  • Foeto-maternal haemorrhage/Kleihauer test IVD kit fluorescent activated cell sorting/flow cytometry (FACS/Flow) :
  • ,
  • Protease immunohaematology reagent IVD :
  • ,
  • Multiple immunohaematology test IVD control :
  • ,
  • Rhesus phenotype-specific reagent red blood cell (C/c/D/E/e/C^w) IVD kit agglutination :
  • ,
  • Anti-Co^b red blood cell grouping IVD antibody :
  • ,
  • Antibody screening reagent red blood cell IVD kit agglutination :
  • ,
  • Red cell antibody eluting IVD reagent :
  • ,
  • Weak anti-D IVD control :
  • ,
  • Anti-C [RH0004] antibody screen IVD control :
  • ,
  • Anti-Fy^a antibody screen IVD control :
  • ,
  • Anti-K antibody screen IVD control :
  • ,
  • Dithiothriotol (DTT) reagent IVD :
  • ,
  • Group AB serum IVD control :
  • ,
  • Red cell antibody diluent IVD reagent :
  • ,
  • Papain immunohaematology reagent IVD :
  • ,
  • Antibody identification panel reagent red blood cell IVD kit agglutination :
  • ,
  • Antibody screening reagent red blood cell IVD kit agglutination :
  • ,
  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD kit agglutination :
NIBEC Co. Ltd.lwol electricity-electronic Agro-industrial Complex 116 Bamdi-gil
lwol-myeon
Chungcheongbuk-do
Jincheon-gun 27816

South Korea

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
06/03/202115126
  • Dental bone matrix implant animal-derived : Dental bone matrix implant animal-derived Conformity Assessment Certificate Expired
  • ,
  • General oral wound dressing animal-derived :
Nibotechnics nvHeikant 5

Hamont-Achel
3930

Belgium

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
06/22/202225042
  • Fixed patient lifting system manual :
Nic Sproson the Optician Ltd52 Barbourne Road

Worcester
Worcestershire WR1 1JA

United Kingdom







04/11/20227168
  • Prescribed Spectacles :
NICHIBAN CO. LTD2-3-3 Sekiguchi

Bunkyo-Ku Tokyo
112-8663

Japan

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
07/11/202225237
  • Adhesive bandage :
  • ,
  • Adhesive bandage :
Nichiryo Co Ltd2760-1 Nishikata

Koshigaya-shiSaitama
343-0822

Japan

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
12/22/202121355
  • Mechanical micropipette IVD :
Nicholas Little (Winterborn & Little Associates Ltd)29 Monk Road
Bishopston
Bristol
BS7 8LE

United Kingdom







11/28/20065398
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic spring :
  • ,
  • Orthodontic appliance system bonded :
Nicholas Watson Opticians LtdNicholas Watson Opticians Ltd 469 Lord Street

Southport
Lancashire PR9 0AQ

England United Kingdom







04/08/20225037
  • Prescribed Spectacles :
Nicholson EyecareNicholson Eyecare 1 Runnymeade Ringwood Road
Bransgore
Christchurch
Dorset BH23 8NJ

United Kingdom







07/17/20198850
  • Prescription spectacles :
NICHROMINOX18 Rue Des Freres LUMIERE

SAINT BONNET DE MURE
F-69720

France

ALS International Ltd Trading as I3CGLOBAL(UK)UK Responsible PersonOffice 54 58 Peregrine Road
Hainault
Ilford
Essex IG6 3SZ
UK Responsible Person
England United Kingdom
04/15/202223488
  • Instrument tray reusable :
  • ,
  • Hand-held dental retractor :
  • ,
  • Dental mirror reusable :
  • ,
  • Instrument tray reusable :
nick smith dental30 redbridge close

ilkeston
derbyshire de75bz

England United Kingdom







07/12/202116028
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Partial denture :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Denture trial fabrication wax :
  • ,
  • Bite registration rim wax :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Denture reliner hard :
NICo-Lab BVPaasheuvelweg 25 Tower B6

Amsterdam
Other... 1105 BP

Netherlands

Matt ProctorUK Responsible Person19 Patch Wood View Newmillerdam

Wakefield
West Yorkshire WF2 6TU
UK Responsible Person
England United Kingdom
06/24/202115526
  • X-ray image interpretive software :
  • ,
  • X-ray image interpretive software :
Nidacon International ABFlöjelbergsgatan 16B
Mölndal
Mölndal
Västra Götaland 431 37

Sweden

Hunter Scientific LtdUK Responsible PersonUnit 1 Priors Hall Widdington

Saffron Walden
Essex CB11 3SB
UK Responsible Person
United Kingdom
01/27/202213633
  • IVF medium kit :
  • ,
  • Assisted reproduction centrifuge tube :
  • ,
  • Sperm filtration system :
  • ,
  • IVF medium :
  • ,
  • Spermatozoa/semen motility medium supplement : Spermatozoa/semen motility medium supplement Conformity Assessment Certificate Expired
NIDEK CO. LTD.34-14 Maehama Hiroishi-cho
Gamagori
Aichi
443-0038

Japan

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
02/08/202213691
  • Posterior-chamber intraocular lens pseudophakic :
  • ,
  • Scanning-laser ophthalmic imaging system :
  • ,
  • Posterior eye segment analyser software :
  • ,
  • Retinal image analysis software :
  • ,
  • Ophthalmodiastimeter :
  • ,
  • Instrument table :
  • ,
  • Vision testing/training chart :
  • ,
  • Ophthalmic slit lamp examination :
  • ,
  • Visual acuity projector :
  • ,
  • Automated lensmeter :
  • ,
  • Eye anterior segment analyser software :
  • ,
  • Phacoemulsification/vitrectomy system :
  • ,
  • Automated ophthalmic refractometer :
  • ,
  • Keratoscope powered :
  • ,
  • Perimeter automatic :
  • ,
  • Ophthalmic solid-state laser system photodisruption :
  • ,
  • Corneal topography system :
  • ,
  • Ophthalmic tonometer line-powered :
  • ,
  • Patient monitoring system module data memory :
  • ,
  • Ophthalmic ultrasound imaging system :
  • ,
  • Gonioscope :
  • ,
  • Bench-top keratometer :
  • ,
  • General/multiple surgical frequency-doubled solid-state laser system :
  • ,
  • Eye anterior segment analyser :
  • ,
  • Phoropter :
  • ,
  • Ultrasound pachymeter :
  • ,
  • Ophthalmic slit lamp examination :
  • ,
  • Ophthalmic fundus camera :
  • ,
  • Ophthalmic fundus camera :
  • ,
  • Retinal optical coherence tomography system :
  • ,
  • Retinal optical coherence tomography system :
Nidek Medical Products Inc.3949 Valley East Industrial Drive

Birmingham
Alabama 35217

United States

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202212234
  • Stationary oxygen concentrator :
  • ,
  • Mobile/portable oxygen concentrator :
NIHON KOHDEN CORPORATION1-31-4 Nishiochiai Shinjuku-ku

Tokyo
Tokyo 1618560

Japan

NIHONKOHDEN UK LTDUK Responsible PersonUnit 3 Heyworth Business Park Old Portsmouth Road Peasmarsh
GUILDFORD
GUILDFORD
Surrey GU3 1AF
UK Responsible Person
England United Kingdom
admin@nihonkohden.co.uk
04/28/202213974
  • Electroencephalograph :
  • ,
  • Evoked-potential graphic recording system :
  • ,
  • Evoked-potential graphic recording system :
  • ,
  • Electrocardiograph professional multichannel :
  • ,
  • Physiologic-monitoring defibrillation system :
  • ,
  • Physiologic-monitoring defibrillation system :
  • ,
  • Carbon dioxide monitor :
  • ,
  • Pulse oximeter probe single-use :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Electroencephalography telemetric monitoring system :
  • ,
  • Electrocardiography telemetric monitoring system receiver :
  • ,
  • Electrocardiography telemetric monitoring system receiver :
  • ,
  • Electrocardiography telemetric monitoring system transmitter :
  • ,
  • Patient monitoring system module carbon dioxide :
  • ,
  • Patient monitoring system module multiple-gas :
  • ,
  • Pulse oximeter probe reusable :
  • ,
  • Centralized patient monitor :
  • ,
  • Centralized patient monitor :
  • ,
  • Neonatal/adult intensive-care ventilator :
  • ,
  • Neonatal/adult intensive-care ventilator :
  • ,
  • Neurophysiologic monitoring system :
  • ,
  • Neurophysiologic monitoring system :
  • ,
  • Non-rechargeable public semi-automated external defibrillator :
  • ,
  • Internal defibrillator electrode adult : Internal defibrillator electrode adult Conformity Assessment Certificate Expired
  • ,
  • External defibrillator electrode pad :
  • ,
  • Electrode conductive medium :
  • ,
  • Electroencephalograph :
  • ,
  • Electroencephalograph :
  • ,
  • Evoked-potential graphic recording system :
  • ,
  • Evoked-potential graphic recording system :
  • ,
  • Electrocardiograph professional multichannel :
  • ,
  • Electrocardiograph professional multichannel :
  • ,
  • Physiologic-monitoring defibrillation system :
  • ,
  • Physiologic-monitoring defibrillation system :
  • ,
  • Pulse oximeter probe single-use :
  • ,
  • Pulse oximeter probe single-use :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Secondary battery :
  • ,
  • Electrocardiographic electrode single-use :
  • ,
  • Electroencephalography telemetric monitoring system :
  • ,
  • Electroencephalography telemetric monitoring system :
  • ,
  • Electrocardiography telemetric monitoring system receiver :
  • ,
  • Electrocardiography telemetric monitoring system transmitter :
  • ,
  • Patient monitoring system module carbon dioxide :
  • ,
  • Patient monitoring system module multiple-gas :
  • ,
  • Patient monitoring system module multiple-gas :
  • ,
  • Centralized patient monitor :
  • ,
  • Centralized patient monitor :
  • ,
  • Neonatal/adult intensive-care ventilator :
  • ,
  • Electrocardiographic electrode reusable :
  • ,
  • Flexible video intubation laryngoscope reusable :
  • ,
  • Neurophysiologic monitoring system :
  • ,
  • Non-rechargeable public semi-automated external defibrillator :
  • ,
  • Cardiopulmonary resuscitation feedback device electronic :
  • ,
  • Patient monitoring system module pulse oximetry :
  • ,
  • Video intubation laryngoscope blade :
Nihon Kohden Digital Health Solutions Inc.14 Bunsen

Irvine
CA 92618

United States

NIHONKOHDEN UK LTDUK Responsible PersonUnit 3 Heyworth Business Park Old Portsmouth Road Peasmarsh
GUILDFORD
GUILDFORD
Surrey GU3 1AF
UK Responsible Person
England United Kingdom
admin@nihonkohden.co.uk
07/05/202225196
  • Medical networking interface unit :
  • ,
  • Bedside physiologic monitor remote-viewing software :
Nihon Kohden Firenze S.r.l.Via Torta 72/74

Sesto Fiorentino Firenze
FI Florence 50019

Italy

NIHONKOHDEN UK LTDUK Responsible PersonUnit 3 Heyworth Business Park Old Portsmouth Road Peasmarsh
GUILDFORD
GUILDFORD
Surrey GU3 1AF
UK Responsible Person
England United Kingdom
admin@nihonkohden.co.uk
08/11/202116729
  • Buffered sample diluent IVD automated/semi-automated system :
  • ,
  • Wash/cleaning solution IVD automated/semi-automated system :
  • ,
  • Blood cell lysis reagent IVD :
Nihon Kohden OrangeMed Inc.1800 E. Wilshire Ave.

Santa Ana
CA California 92705

United States

NIHONKOHDEN UK LTDUK Responsible PersonUnit 3 Heyworth Business Park Old Portsmouth Road Peasmarsh
GUILDFORD
GUILDFORD
Surrey GU3 1AF
UK Responsible Person
England United Kingdom
admin@nihonkohden.co.uk
08/04/202116532
  • Neonatal/adult intensive-care ventilator :
Nikkiso Belgium bvIndustriepark 6

Tienen
3300

Belgium

NIKKISO UK CO. LTD.UK Responsible PersonUnit 2 Ashfields Farm Priors Court Road

Hermitage
RG18 9XY
UK Responsible Person
England United Kingdom
08/04/202116475
  • Hollow-fibre haemodialysis dialyser single-use :
Nikkiso Co. Ltd.Yebisu Garden Place Tower 22nd Floor 20-3 Ebisu 4-Chome Shibuya-ku

Tokyo
150-6022

Japan

TTR MedTech Consultancy LimitedUK Responsible Person5 Sansome Drive

Hinckley
LE10 0YJ
UK Responsible Person
England United Kingdom
09/23/202117754
  • Apheresis system :
  • ,
  • Apheresis system tubing set :
NIKKISO CO. LTD.20-3 Ebisu 4-Chome Shibuya-ku

Tokyo
150-6022

Japan

FREYR LIFE SCIENCES LTDUK Responsible Person9 Greyfriars Road

Reading
Berkshire RG1 1NU
UK Responsible Person
England United Kingdom
UKRP@FREYRSOLUTIONS.COM
10/04/202118088
  • Haemodialysis system dialysate pyrogen filter :
  • ,
  • Haemodialysis system dialysate delivery unit :
  • ,
  • Hollow-fibre haemodialysis dialyser single-use :
  • ,
  • Haemodialysis blood tubing set single-use :
Nikkiso Europe GmbHDesbrocksriede 1

Langenhagen
30855

Germany

NIKKISO UK CO. LTD.UK Responsible PersonUnit 2 Ashfields Farm Priors Court Road

Hermitage
RG18 9XY
UK Responsible Person
England United Kingdom
08/05/202116474
  • Haemofiltration system :
Nikon-Essilor10-8 Ryogoku 2-chome Sumida-ku

Tokyo
130-0026

Japan

Nikon Optical UK LtdUK Responsible Person3 Tanners Drive Blakelands

Milton Keynes
Buckinghamshire MK14 5BU
UK Responsible Person
United Kingdom
04/05/202221092
  • Tinted spectacle lens prescription custom-made :
  • ,
  • Spectacle frame :
  • ,
  • Prescription spectacle lens custom-made :
  • ,
  • Tinted non-prescription spectacles :
  • ,
  • Prescription spectacle lens non-customized :
  • ,
  • Tinted spectacle lens prescription standard :
Nikon CorporationNAGAODAI-CHO SAKAE-KU
YOKOHAMA-SHI
KANAGAWA
244-8533

Japan

Nikon UK Branch of Nikon Europe BVUK Responsible Person1 The Crescent

Surbiton
Surrey KT6 4BN
UK Responsible Person
England United Kingdom
06/08/202115094
  • Basic light microscope IVD :
  • ,
  • Inverted-stage light microscope :
Nikon Optical UK Ltd3 Tanners Drive Blakelands

Milton Keynes
Buckinghamshire MK14 5BU

United Kingdom







04/05/20222503
  • Spectacle Frames :
  • ,
  • Spectacle Lenses :
Nimco Made4you B. V.Oude Kleefsebaan 119

Berg en Dal
Provincie Gelderland 6572 AK

Netherlands

DeNovo Healthcare LtdUK Responsible PersonUnit 6a Cheddar Business Park Wedmore Road

Cheddar
Somerset BS27 3EB
UK Responsible Person
England United Kingdom
01/10/202221684
  • Orthotic shoe custom-made :
  • ,
  • Orthotic shoe non-customized :
Nimrodental LtdBischeim House Basement Floor
19-20 Berners Street
London
W1T 3NW

United Kingdom







07/07/20144648
  • Dental Appliances/Prostheses :
  • ,
  • Orthodontic palate expander/teeth aligner bonded :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Orthodontic appliance system self-removable :
  • ,
  • Orthodontic archwire :
  • ,
  • Orthodontic archwire/bracket ligature :
  • ,
  • Orthodontic bracket ceramic :
  • ,
  • Orthodontic bracket metal :
  • ,
  • Orthodontic bracket plastic reprocessed :
  • ,
  • Orthodontic bracket plastic single-use :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Orthodontic clasp metal preformed :
  • ,
  • Orthodontic metal band :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic space maintainer :
  • ,
  • Orthodontic spring :
  • ,
  • Orthodontic appliance positioning tray :
  • ,
  • Orthodontic appliance/positioning tray kit :
  • ,
  • Dental CAD/CAM system laboratory :
  • ,
  • Orthodontic progressive aligner :
Ningbo Advan Electrical Co. LtdIndustrial Development Zone Fuhai Town Cixi City

Ningbo
Zhejiang 315332

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202216247
  • Skin stapler/staple non-bioabsorbable :
  • ,
  • Skin staple remover single-use :
Ningbo Caremed Medical Products Co. Ltd.No.79 Jiutang Road South Side Hangzhou Bay New Zone

Ningbo
315336

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202215838
  • Autoinjector needle :
Ningbo Chinmed Technology Co. LtdNo.20 Xingzhong Rd Qijiashan Street Beilun Area Ningbo

Zhejiang Province
315803

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
03/29/202223859
  • Exudate-absorbent dressing non-gel non-antimicrobial :
  • ,
  • Exudate-absorbent dressing hydrophilic-gel non-antimicrobial :
  • ,
  • Dressing-fixation skin adhesive tape non-silicone :
Ningbo Five Continents Medical Instrument Co. Ltd63-9 Modao Bridge Road

Yuyao
Zhejiang Province 315400

China

Microport Scientific LimitedUK Responsible PersonWillow House Park West

Chester
CH1 4RW
UK Responsible Person
England United Kingdom
09/02/202117313
  • Disposable surgical irrigation/aspiration system :
Ningbo Greatcare Medical Instruments Co. Ltd.No .92 Cishanhe Rd Chunxiao Beilun

Ningbo
Zhejiang 315830

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
04/22/202224315
  • Non-wearable adult urine collection bag open-ended :
  • ,
  • Urinary incontinence penis sheath/port single-use :
  • ,
  • Non-wearable adult urine collection bag open-ended :
  • ,
  • Urinary incontinence penis sheath/port single-use :
  • ,
  • Wearable adult urine collection bag open-ended :
  • ,
  • Wearable adult urine collection bag open-ended :
Ningbo Greetmed Medical Instruments Co Ltd16F-1 Building 1 No. 98 Chuangyuan Road
Hi Tech Zone
Ningbo
Zhejiang Province 315042

China

Albert Waeschle LtdUK Responsible Person11 Balena Close Creekmoor

Poole
Dorset BH17 7DB
UK Responsible Person
United Kingdom
04/07/202113160
  • Vaginal speculum single-use :
Ningbo Haishu Life Medical Technology Co. Ltd1 Jinghui Road Hengjie Town
Haishu Zhejiang
Hengjie Town
Ningbo 315181

China

MDS Medical LimitedUK Responsible Person93 Headlands

Kettering
Northants NN15 6BL
UK Responsible Person
England United Kingdom
03/24/202222518
  • Steam sterilizer :
Ningbo Ican Machines Co. Ltd.No.77 Yunlin East Road Gulin Town Haishu District

Ningbo
315176

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
07/20/202116088
  • Steam sterilizer :
Ningbo Jenius Polymer Sci-Tech Co. LtdNo.2112 Ningheng South Road Hengxi Town YinZhou District

NingBo
Zhejiang 315131

China

HUA TENG LIMITEDUK Responsible Person3 Glass Street Hanley

Stoke On Trent
ST1 2ET
UK Responsible Person
England United Kingdom
02/04/202222691
  • First aid absorbent pad/bandage :
Ningbo Jianxiang Packaging Material Technology Co. LtdNo.19-2 Miaofeng Road Taoyuan Street

Ningbo
Zhejiang 315600

China

NPZ technology LtdUK Responsible PersonStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE
UK Responsible Person
United Kingdom
03/31/202223934
  • Surgical/medical face mask non-antimicrobial single-use :
Ningbo Liwei Medical Technology Co. LTDC06 1333 Xiaying Duan Yinxian Road Yinzhou District Ningbo City

Zhejiang Province
315105

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
01/23/202222206
  • Limb tourniquet manual single-use :
Ningbo Medsun Medical Co. Ltd.No.55 Jinxi Road Zhenhai

Ningbo
315221

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202217669
  • Blood lancet single-use :
  • ,
  • Skin-cleaning wipe non-sterile :
  • ,
  • Insulin syringe/needle safety :
  • ,
  • Manual blood lancing device single-use :
Ningbo My-BioMed Biotechnology Co. Ltd.Ningbo My-BioMed Biotechnology Co. Ltd. Room 607 Office Building 3 Meishan Avenue Business Center Beilun District

Ningbo City
Zhejiang Province 315800

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
11/18/202120120
  • Microscope slide digital imaging scanner IVD :
Ningbo Runyes Medical Instrument Co. Ltd.032 Building No. 456 Tonghui Road Jianbei Investment & Pioneering Park C

Ningbo
315033

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
04/04/202113072
  • Steam sterilizer :
  • ,
  • Dental chair electric :
  • ,
  • Stationary intraoral dental x-ray system analogue :
  • ,
  • Dental suction system :
  • ,
  • Intraoral optical scanning system :
  • ,
  • Medical device air compressor :
Ningbo Sezen Technology Co. Ltd.2F 13th Building 518 Xinmei Road Yinzhou District

Ningbo
315000

China

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
02/01/202222363
  • Orthodontic progressive aligner :
Ningbo Shengyurui Medical Appliances Co. Ltd.No.138 Binhaisi Road Hangzhou Bay New Zone

Ningbo
Zhejiang 315336

China

Etheria Medical LtdUK Responsible PersonThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA
UK Responsible Person
United Kingdom
04/15/202219724
  • Venturi oxygen face mask :
  • ,
  • Venturi oxygen face mask :
  • ,
  • Tracheostomy mask aerosol :
  • ,
  • Tracheostomy mask aerosol :
  • ,
  • Suction system catheter general-purpose :
  • ,
  • Suction system catheter general-purpose :
  • ,
  • Rebreathing oxygen face mask :
  • ,
  • Rebreathing oxygen face mask :
  • ,
  • Non-rebreathing oxygen face mask :
  • ,
  • Non-rebreathing oxygen face mask :
  • ,
  • CPAP/BPAP face mask single-use :
  • ,
  • CPAP/BPAP face mask single-use :
  • ,
  • Nebulizing system delivery set single-use :
  • ,
  • Nebulizing system delivery set single-use :
  • ,
  • Benchtop nebulizer non-heated :
  • ,
  • Benchtop nebulizer non-heated :
  • ,
  • Heat/moisture exchanger/microbial filter sterile :
  • ,
  • Heat/moisture exchanger/microbial medical gas filter :
  • ,
  • Capnography oxygen mask :
  • ,
  • Capnography oxygen mask :
  • ,
  • Nasal oxygen cannula basic :
  • ,
  • Nasal oxygen cannula basic :
  • ,
  • Anaesthesia breathing circuit single-use :
  • ,
  • Anaesthesia breathing circuit single-use :
  • ,
  • Anaesthesia breathing circuit single-use :
  • ,
  • Anaesthesia breathing circuit single-use :
  • ,
  • Anaesthesia face mask single-use :
  • ,
  • Anaesthesia face mask single-use :
Ningbo Shenyu Medical Equipment Co. Ltd.No. 1318 West of Tanjialing Road Yuyao City Ningbo

Zhejiang Province
315408

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
08/17/202116813
  • Handgrip disability-assistive walker non-powered foldable :
Ningbo Tianyi Medical Appliance Co. Ltd.No.788 Mozhi North Road Tourism Resort
Dongqian Lake
Ningbo
315121

China

LUNDATEC UK LTDUK Responsible PersonFirst Floor 12 Commerce Road Lynch Wood

Peterborough
Cambridgeshire PE2 6LR
UK Responsible Person
England United Kingdom
06/02/202115105
  • Haemodialysis needle :
  • ,
  • Haemofiltration system :
Ningbo Troika Medical Products Company Limited11 Gaoya Rd Jiangshan Town Yinzhou District

Ningbo
315191

China

GNM DISTRIBUTION LIMITEDUK Responsible Person1 Craigmount Drive Corstorphine

Edinburgh
EH12 8DB
UK Responsible Person
Scotland United Kingdom
12/07/202120363
  • Surgical/medical respirator non-antimicrobial single-use :
Ningbo Wise OptoMech Technology CorporationNo.86 Building 11 Innovation Park 128 Qiming Road Yinzhou District

Ningbo
315100

China

MedPath LimitedUK Responsible Person27 Old Gloucester Street

London
WC1N 3AX
UK Responsible Person
England United Kingdom
08/31/202117163
  • Endoscopic video image processing unit :
  • ,
  • Flexible video ureteroscope single-use :
Ningbo Youhuan Automation Technology Co. Ltd.No. 135 Xujia Gujia Village Jiangshan Town Yinzhou District Ningbo

Zhejiang Province
315000

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
05/24/202224748
  • Wheelchair electric-motor-driven attendant/occupant-controlled manual-steering collapsible :
Nipro Corporation3-9-3 Honjo-Nishi Kita-ku

Osaka
531-8510

Japan

Nipro Medical UK LtdUK Responsible PersonUnits 12-14 South Point Ensign Way
Hamble-Le-Rice
Southampton
Hampshire SO31 4RF
UK Responsible Person
England United Kingdom
04/11/202217670
  • Haemodialysis blood tubing set single-use :
  • ,
  • Blood collection set invasive :
  • ,
  • Hypodermic needle single-use :
  • ,
  • Non-fixed blood collection needle :
  • ,
  • Elastomeric infusion pump system :
  • ,
  • Hollow-fibre haemodialysis dialyser single-use :
  • ,
  • Haemodialysis system dialysate pyrogen filter :
  • ,
  • Haemodialysis catheterization kit :
  • ,
  • Peripheral intravenous cannula :
  • ,
  • Basic intravenous administration set invasive :
  • ,
  • Arteriovenous fistula access site scab remover :
  • ,
  • Haemodialysis system institutional :
  • ,
  • Haemodialysis needle :
Nipro India Corporation PVT. LTD.Plot No. E-1/1 Khandala PH-I Industrial area Taluka-Khandala

Maharashtra
District-Satara 412 802

India

Nipro Medical UK LtdUK Responsible PersonUnits 12-14 South Point Ensign Way
Hamble-Le-Rice
Southampton
Hampshire SO31 4RF
UK Responsible Person
England United Kingdom
04/11/202217671
  • Haemodialysis needle :
  • ,
  • Hollow-fibre haemodialysis dialyser single-use :
Nipro Medical (Hefei) Co LtdNo. 350 Yungu Road Economic & Technological Development Zone

Hefei
230601

China

Nipro Medical UK LtdUK Responsible PersonUnits 12-14 South Point Ensign Way
Hamble-Le-Rice
Southampton
Hampshire SO31 4RF
UK Responsible Person
England United Kingdom
04/11/202217912
  • Hollow-fibre haemodialysis dialyser single-use :
Nipro Pure Water GmbHWerner Von Siemensstr. 2-6

Bruchsal
76646

Germany

Nipro Medical UK LtdUK Responsible PersonUnits 12-14 South Point Ensign Way
Hamble-Le-Rice
Southampton
Hampshire SO31 4RF
UK Responsible Person
England United Kingdom
04/11/202219080
  • Reverse-osmosis water purification system :
Nipro Renal Solutions Spain S.L.U.Pol. Ind. Tumsa nave no 31

Mollerussa
Lleida E-25230

Spain

Nipro Medical UK LtdUK Responsible PersonUnits 12-14 South Point Ensign Way
Hamble-Le-Rice
Southampton
Hampshire SO31 4RF
UK Responsible Person
England United Kingdom
04/11/202217278
  • Haemodialysis concentrate :
Nissha Medical Technologies LtdTorbay Business Park Woodview Road

Paignton
Devon TQ4 7HP

United Kingdom







06/23/20155692
  • Electrocardiographic electrode single-use :
  • ,
  • Electrosurgical return electrode single-use :
  • ,
  • Medical printer paper :
Nissha Medical Technologies SAS23-25 Boulevard de la Paix

Cergy
95800

France

Nissha Medical Technologies LtdUK Responsible PersonTorbay Business Park Woodview Road

Paignton
Devon TQ4 7HP
UK Responsible Person
United Kingdom
11/09/202119317
  • Cardiac ablation system irrigation tubing set :
  • ,
  • Endoscopic insufflation tubing set single-use :
  • ,
  • Surgical irrigation tubing set single-use :
  • ,
  • Electrocardiographic electrode single-use :
  • ,
  • Electrocardiographic lead set reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Blood pressure cuff reusable :
NitNOT Limited102 Metroline House 118-122 College Road

Harrow
Middlesex HA1 1BQ

England United Kingdom







03/15/202112687
  • Lice comb manual :
  • ,
  • Lice treatment solution synthetic :
NK Technology Ltd.International House 24 Holborn Viaduct

London
EC1A 2BN

England United Kingdom







12/02/202120594
  • Wrist orthosis :
No7 Contact Lens Laboratory LtdUnit 3 Highfields Business Park Sidney Little Road

Hastings
East Sussex TN38 9UB

United Kingdom







11/28/20199349
  • Soft corrective contact lens daily-disposable :
  • ,
  • Hybrid corrective contact lens custom-made :
  • ,
  • Soft corrective contact lens daily-wear :
  • ,
  • Orthokeratology contact lens :
  • ,
  • Rigid-gas-permeable corrective contact lens daily-wear :
  • ,
  • Rigid-gas-permeable corrective contact lens daily-wear :
Noakes Habermehl & Kerr6 Fore Street

Ivybridge
Devon PL21 9AB

England United Kingdom







09/26/20123959
  • Prescribed Spectacles :
Nobel Biocare ABVästra Hamngatan 1 PO Box 5190 402 26

Göteborg
41117

Sweden

Nobel Biocare UK Ltd.UK Responsible Person4 Longwalk Road
Stockley Park
Uxbridge
Middlesex UB11 1FE
UK Responsible Person
England United Kingdom
regulatory.affairs.nb@envistaco.com
04/28/202213928
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Bone tap reusable :
  • ,
  • Bone tap reusable :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant extractor :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental soft-tissue coring punch reusable :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Bone tap single-use sterile :
  • ,
  • Screw extractor single-use :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Instrument tray reusable :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical torque wrench reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Surgical drill guide reusable :
  • ,
  • Dressing/utility forceps tweezers-like reusable :
  • ,
  • General-purpose dental x-ray system application software :
  • ,
  • Dental osteotome set :
  • ,
  • Dental torque wrench :
  • ,
  • Dental torque wrench :
  • ,
  • Dental torque wrench :
  • ,
  • Dental torque wrench :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Periotome reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental implantation drilling template retention pin :
  • ,
  • Dental implant x-ray template :
  • ,
  • CAD/CAM software :
  • ,
  • Surgical drill guide single-use :
  • ,
  • Dental guided surgery reference plate :
  • ,
  • Luer/non-ISO80369-standardized linear connector reusable :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Screw extractor reusable :
  • ,
  • Screw extractor reusable :
  • ,
  • Dental implant suprastructure temporary preformed reusable :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Instrument tray reusable :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Radiology DICOM image processing application software :
  • ,
  • Dental treatment application software :
  • ,
  • Bone tap reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Fixture/appliance dental drill bit single-use :
  • ,
  • CAD/CAM software :
  • ,
  • Dental prosthesis/implant abutment screw :
Nobel Biocare UK Ltd.4 Longwalk Road
Stockley Park
Uxbridge
Middlesex UB11 1FE

England United Kingdom

regulatory.affairs.nb@envistaco.com






04/23/202113764
  • Fixture/appliance dental drill bit single-use :
Nobil Metal SpAStrada San Rocco 28

Villafranca d'Asti
Asti 14018

Italy

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202216376
  • Dental appliance fabrication material ceramic :
  • ,
  • Dental casting non-noble alloy :
  • ,
  • Dental casting non-noble alloy :
  • ,
  • Dental casting noble alloy :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Resilient dental precision attachment :
  • ,
  • Dentine bonding agent/set :
  • ,
  • Resilient dental precision attachment :
Noble Biosciences Inc.13-50 Sinbaek-gil Jeongnam-myeon

Hwaseong-si
Gyeonggi-do 18521

South Korea

MT Promedt Consulting LtdUK Responsible PersonBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP
UK Responsible Person
England United Kingdom
01/21/202221637
  • General-purpose absorbent tip applicator/swab single-use :
Noble Eye Centre Ltd89 High Street

Rushden
NN100NZ

United Kingdom







08/01/20062682
  • Prescribed Spectacles :
Nobles Medical Technologies II Inc.17072 Newhope Street

Fountain Valley CA
92708

United States

Wellkang LtdAuthorised Representative (Northern Ireland) UK Responsible PersonEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE
Authorised Representative (Northern Ireland) UK Responsible Person
Northern Ireland United Kingdom
12/29/202120932
  • Polyolefin suture monofilament :
Nonacus LimitedBioHub Birmingham Research Park 97 Vincent Drive

Birmingham
West Midlands B15 2SQ

United Kingdom







12/07/202011077
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • SARS-CoV-2/influenza A/B nucleic acid IVD kit nucleic acid technique (NAT) :
Nonin Medical Inc.13700 1st Avenue N

Plymouth
Minnesota 55441

United States

Emergo Consulting (UK) Limited UK Responsible PersonCompass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ
UK Responsible Person
England United Kingdom
01/13/202221250
  • Pulse oximeter probe single-use :
  • ,
  • Cerebral oximeter sensor single-use :
  • ,
  • Pulse oximeter probe reusable :
  • ,
  • Pulse oximeter probe single-use :
  • ,
  • Pulse oximeter probe/processor :
  • ,
  • Pulse oximeter :
  • ,
  • Medical equipment clinical data interfacing software :
NOPA Instruments Medizintechnik GmbHWeilatten 7-9

Tuttlingen
78532

Germany

Cutting Edge Surgical Instruments LimitedUK Responsible Person1 Tower House Tower Centre
Hoddesdon
Hoddesdon
Hertfordshire EN11 8UR
UK Responsible Person
England United Kingdom
01/21/202221648
  • Spring-loaded pneumoperitoneum needle single-use :
  • ,
  • Bone cutter :
  • ,
  • Vaginal dilator :
  • ,
  • Neurosurgical bone flap elevator :
  • ,
  • Open-surgery biopsy forceps reusable :
  • ,
  • Sterilizer transfer forceps :
  • ,
  • Nail clippers reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Bandage scissors reusable :
  • ,
  • Nasal scissors :
  • ,
  • Neurosurgical scissors :
  • ,
  • Suture scissors :
  • ,
  • Tonsil snare :
  • ,
  • Cast spreader :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Tonsillectome :
  • ,
  • Nasal snare reusable :
  • ,
  • Cast cutter line-powered :
  • ,
  • Static powered traction system :
  • ,
  • Urethrotome :
  • ,
  • Orthodontic retainer :
  • ,
  • Rectal speculum :
  • ,
  • Rigid endoscopic biopsy forceps reusable :
  • ,
  • Dental root separator :
NORAS MRI Products GmbHLeibnizstrasse 4

Höchberg
Bavaria 97204

Germany

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202217638
  • MRI system coil radio-frequency :
  • ,
  • MRI system coil radio-frequency :
Norav Medical Ltd4 Hamada Street / PO Box 81 Yokneam Industrial Park

Hadera
2069202

Israel

Physiological Measurements LimitedUK Responsible PersonThe Old Malt House Willow Street

Oswestry
Shropshire SY11 1AJ
UK Responsible Person
England United Kingdom
04/04/202224001
  • Electrocardiographic signal amplifier :
  • ,
  • Electrocardiography telemetric monitoring system transmitter :
  • ,
  • Electrocardiographic long-term ambulatory recording analyser application software :
  • ,
  • Electrocardiographic ambulatory recorder :
  • ,
  • Electrocardiography telemetric monitoring system receiver :
  • ,
  • Diagnostic spirometer professional :
  • ,
  • Electrocardiographic lead set reusable :
  • ,
  • Electrocardiograph professional single-channel :
Noraxon USA Inc.15770 Greenway-Hayden Loop Suite 100

Scottsdale
Arizona 85260

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
05/27/202220207
  • Kinesiology/electromyographic sensor set :
  • ,
  • Biofeedback system application software :
NordicNeuroLab ASMøllendalsveien 1

Bergen
5009

Norway

QAdvis UK LtdUK Responsible Person55-66 Frederick Street

Edinburgh EH2 1LS
EH2 1LS
UK Responsible Person
Scotland United Kingdom
09/30/202117943
  • Interactive-evaluation patient hand-controller :
  • ,
  • MRI system application software :
  • ,
  • Visual stimulator :
  • ,
  • Visual stimulator :
  • ,
  • MRI system synchronizer :
  • ,
  • MRI system application software :
Norfolk & Norwich University Hospital NHS TrustThe Cotman Centre Colney Lane Colney

Norwich
Norfolk NR4 7UB

United Kingdom







10/10/20062957
  • Ward Dressing Packs :
  • ,
  • Theatre Dressing Packs :
  • ,
  • Ophthalmic Surgical Procedure Packs :
  • ,
  • Orthodontic Procedure Packs :
  • ,
  • Surgical Procedure Packs (Includes Instruments Supplied Singularly) :
Norgine B.VAntonio Vivaldistraat
Antonio Vivaldistraat Amsterdam
Amsterdam
Provincie Noord-Holland 1083 HP

Netherlands

Norgine Pharmaceuticals LimitedUK Responsible PersonNorgine House Widewater Place
Moorhall Road Harefield
Uxbridge
UB9 6NS
UK Responsible Person
United Kingdom
07/07/202115790
  • Cognitive assessment software :
Noris Medical Ltd8 Hataasia st.

Nesher
3688808

Israel

Easy Medical Device LimitedUK Responsible Person125 Deansgate

Manchester
M3 2LH
UK Responsible Person
Wales United Kingdom
04/26/202113851
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental/maxillofacial surgical procedure kit non-medicated reusable :
  • ,
  • Screw endosteal dental implant two-piece :
Norlase ApSBrydehusvej 13

Ballerup
CVR 356445547

Denmark

SIGMACON (UK) LimitedUK Responsible PersonPalladium House 1-4 Argyll Street

LONDON
W1F7LD
UK Responsible Person
England United Kingdom
info@sigmacon.co.uk
02/11/202222850
  • Slit lamp/laser system control interface :