Manufacturer's By Name

Manufacturer Address Authorised Representative/UK Responsible Person Relationship Address Date Registered MHRA Reference Number Devices
Gambro Dasco S.p.A trading as Baxter MedollaVia Modenese 66

Medolla
MO 41036

Italy

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
07/28/202116256
  • Haemodialysis system dialysate delivery unit :
  • ,
  • Haemodialysis blood tubing set single-use :
  • ,
  • Haemodialysis system dialysate pyrogen-filtration set :
  • ,
  • Haemodialysis system dialysate pyrogen-filtration set :
  • ,
  • Haemodialysis blood tubing set single-use :
  • ,
  • Haemodialysis blood tubing set single-use :
Gambro Dialysatoren GmbH trading as Baxter HechingenHolger-Crafoord-Strasse 26

Hechingen
72379

Germany

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
07/28/202116224
  • Hollow-fibre haemodialysis dialyser single-use :
  • ,
  • Microbial water purification filter sterilizable :
Gambro Lundia AB trading as Baxter LundBox 10101 Magistrtsvagen 16

Lund
SE-220 10

Sweden

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
08/04/202116545
  • Haemodialysis system institutional :
  • ,
  • Haemodialysis system institutional/home-use :
  • ,
  • Haemodialysis concentrate :
  • ,
  • Sodium carbonate haemodialysis system cleaning cartridge :
  • ,
  • Citric acid haemodialysis system cleaning cartridge :
  • ,
  • Reverse-osmosis water purification system :
Gambro Renal Products Inc trading as Baxter Opelika1101 Jeter Avenue

Alabama
Opelika AL 36801

United States

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
07/28/202116215
  • Hollow-fibre haemodialysis dialyser single-use :
Gambro Renal Products S.A. de C.V. trading as Baxter TijuanaBoulevard Pacifico No. 10014 Parque Industrial Pacifico

Tijuana
Baja California C.P. 22643

Mexico

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
03/18/202223708
  • Haemodialysis blood tubing set single-use :
Gambro UF Solutions Inc. trading as Baxter Brooklyn Park7601 Northland Drive Suite 170 Brooklyn Park

Minnesota
55428

United States

Baxter Healthcare LtdUK Responsible PersonCaxton Way

Thetford
Norfolk IP24 3SQ
UK Responsible Person
England United Kingdom
12/13/202120548
  • Extracorporeal circuit waste bag sterile :
  • ,
  • Intravenous administration tubing extension set :
Gamida Tech S.A.R.L.31 Rue Des Alouettes FR95600 Eaubonne

Eaubonne
FR95600

France

Deltex Medical LimitedUK Responsible PersonTerminus Road

Chichester
West Sussex PO19 8TX
UK Responsible Person
United Kingdom
09/15/202117563
  • Intravascular/intracavitary-circulation hyperthermia system :
  • ,
  • Intravascular/intracavitary-circulation hyperthermia system set :
  • ,
  • Intravascular/intracavitary-circulation hyperthermia system set :
Gammex Inc.7600 Discovery Drive

Middleton WI
53562

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
05/12/202224611
  • CT phantom test object :
  • ,
  • Laser patient positioning system :
  • ,
  • Mammographic x-ray phantom test object :
GANA R&D Co. Ltd.103 905 555 Dunchon-daero Jungwon-gu

Seongnam-si
Gyeonggi-do 13215

South Korea

Sinclair Pharmaceuticals LimitedUK Responsible PersonEden House Lakeside
Chester Business Park
Chester
CH4 9QT
UK Responsible Person
United Kingdom
04/19/202213325
  • Dermal tissue reconstructive material synthetic polymer bioabsorbable :
Gannow Dental Laboratory LtdUnit 14 Oak Street Industrial Park Oak Street

Cradley Heath
West Midlands B64 5JY

United Kingdom







09/24/20155686
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Partial denture :
Ganshorn Medizin Electronic GMBHIndustrie-Strasse 6-8

Niederlauer
97618

Germany

Schiller UK LtdUK Responsible Person200 Brook Drive Green Park

Reading
Berkshire RG2 6UB
UK Responsible Person
England United Kingdom
09/09/202117349
  • Diagnostic spirometer professional :
  • ,
  • Whole-body plethysmograph :
  • ,
  • Pulmonary function analysis system adult :
  • ,
  • Cardiopulmonary stress exercise monitoring system :
  • ,
  • Benchtop nebulizer non-heated :
Gap Research Co LtdUnit 2 Ebbsfleet Business Park Stonebridge Road
Northfleet DA11 9DZ
Gravesend
Kent DA11 9DR

United Kingdom







11/10/20156946
  • Dental polishing cup single-use :
  • ,
  • Dental-professional prophylaxis brush reusable :
  • ,
  • Home-use dental cement :
  • ,
  • Denture reliner soft home-use :
  • ,
  • Carboxymethylcellulose sodium/cationic polyacrylamide polymer denture adhesive :
  • ,
  • Denture repair kit home-use :
  • ,
  • Dental cavity varnish solvent :
  • ,
  • Periodontal pick/brush reusable :
  • ,
  • Dental impression material adhesive :
Gareth Morgan2 Llundainfach
Abercrave
Swansea
Powys SA9 1ST

Wales United Kingdom
07761650346
cathgareth84@hotmail.com






04/05/20222707
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Partial denture :
  • ,
  • Overdenture :
  • ,
  • Custom-made mouthguard :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Orthodontic progressive aligner :
  • ,
  • Orthodontic clasp metal wire custom-made :
Garrison Dental Solutions LLC150 DeWitt Lane

Spring Lake
Michigan 49456

United States

Eurolink (Europe) LimitedUK Responsible PersonMilestone House Longcot Road
Shrivenham
Swindon
Wilts SN6 8AL
UK Responsible Person
United Kingdom
04/13/202221015
  • Dental dressing forceps reusable :
  • ,
  • Dental matrix band retainer :
  • ,
  • Dental abrasive strip single-use :
  • ,
  • Dental matrix band single-use :
  • ,
  • Dental restoration carver resin :
  • ,
  • Dental wedge single-use :
  • ,
  • Dental matrix band kit :
  • ,
  • Dental matrix band kit :
Garstang Dental Referral PracticeWeind House Park Hill Road Garstang

Preston
Lancashire PR3 1EL

United Kingdom







04/06/20223664
  • Complete lower denture :
Gary WilliamsDouble Barn Cottage Clay Lane

Chichester
PO18 8AB

England United Kingdom







09/17/202118710
  • Spectacle frame :
  • ,
  • Tinted non-prescription spectacles :
Gas Arc Group Limited6th Floor 322 High Holborn

London
WC1V 7PB

England United Kingdom







12/17/202121191
  • Medical gas pipeline system :
Gas Control Equipment LTD100 Empress Park Penny Lane
Haydock
St Helens
WA119DB

United Kingdom







02/27/20198548
  • Mobile/portable oxygen concentrator :
Gastrex Sarl27 av. Recteur Marcel Bouchard F - 21 21 640 Gilly-Les-Citeaux

Gilly-Les-Citeaux
21 640

France

PENTLAND MEDICAL LTDUK Responsible Person157 Broomhall Crescent

EDINBURGH
EH12 7PJ
UK Responsible Person
Scotland United Kingdom
04/08/202221316
  • Helicobacter pylori antigen IVD kit fluorescent immunoassay rapid :
Gatema Medical s.ro.Prmyslová 2503/2

Boskovice
680 01

Czechia

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
04/14/202220874
  • Medical image management system :
GAUKE Healthcare Co. Ltd.No. 82 TuanFeng Avenue TuanFeng Town TuanFeng

Huang Gang
Hubei 438800

China

KINGSMEAD SERVICE LIMITEDUK Responsible Person19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
12/02/202120265
  • Cardiopulmonary resuscitation mask single-use :
  • ,
  • Traction bandage :
  • ,
  • Tongue depressor surgical :
  • ,
  • Eye wash cup :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Dressing/utility forceps scissors-like single-use :
  • ,
  • General-purpose surgical scissors single-use :
  • ,
  • Adhesive bandage :
  • ,
  • Rescue blanket reusable :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Vinyl examination/treatment glove non-powdered :
  • ,
  • Hypoallergenic skin adhesive tape :
  • ,
  • Non-adhesive device retention bandage :
  • ,
  • Medical device cleaning/disinfection wipe :
  • ,
  • Limb tourniquet manual single-use :
  • ,
  • First aid kit non-medicated single-use :
Gauthier Biomedical Inc.2221 Washington St.

Grafton WI
53024

United States

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
01/24/202222171
  • Surgical instrument handle torque-limiting :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic surgical distractor internal :
  • ,
  • Orthopaedic surgical distractor external :
  • ,
  • Surgical screwdriver reusable :
GB PPE LimitedMartland Mill Mart Lane Ormskirk

Burscough
Lancashire L40 0SD

England United Kingdom







05/10/202114577
  • Surgical/medical face mask single-use :
GBM Authorised Representative LtdThe White House 2 Meadrow

Godalming
Surrey GU7 3HN

England United Kingdom
+44(0)7710039721
martin.biggs@mba-gbm.com






04/10/20226971
  • Bandages (Eg Support/Tubular/Adhesive/Plaster Of Paris/Cast Liners/Resin) :
  • ,
  • Dental Unit Accessories :
  • ,
  • X-Ray Cassettes Cassette Holders Image Enhancers And Intensifying Screens :
GBUK Group LtdBlackwood Hall Business Park North Duffield

Selby
N. Yorks YO8 5DD

United Kingdom







04/09/20225511
  • Oral/enteral syringe drawing-up straw :
  • ,
  • Suction system filter microbial :
  • ,
  • Blood pressure cuff reusable :
  • ,
  • Gastrostomy procedure kit :
  • ,
  • Bedside syringe pump :
  • ,
  • Fluid transfer tube general-purpose :
  • ,
  • ENFit oral/enteral syringe single-use :
  • ,
  • Vial/bottle adaptor non-hermetic :
  • ,
  • Gastric drainage/decompression bag :
  • ,
  • Closed-wound drainage kit :
  • ,
  • Closed-wound drainage kit :
  • ,
  • Pelvic-organ-supporting pessary :
  • ,
  • Intestinal/urinary stoma button :
  • ,
  • Enteral tube extension sterile :
  • ,
  • Pericardiocentesis catheter :
  • ,
  • Nasogastric feeding tube :
  • ,
  • Nasogastric feeding tube :
  • ,
  • Cerebrospinal fluid manometer mechanical :
  • ,
  • Intrathecal anaesthesia set non-medicated :
  • ,
  • Intrathecal anaesthesia set non-medicated :
  • ,
  • Medication transfer needle filtering :
  • ,
  • Medication transfer needle non-filtering/non-vented :
  • ,
  • Medication transfer straw :
  • ,
  • Neuraxial syringe :
  • ,
  • Neuraxial syringe :
  • ,
  • ENFit oral/enteral syringe reusable :
  • ,
  • ENFit oral/enteral syringe reusable :
  • ,
  • Suction system catheter general-purpose :
  • ,
  • Airway suction catheter :
  • ,
  • Pericardiocentesis catheter :
  • ,
  • ENFit oral/enteral syringe single-use :
  • ,
  • Needle guide single-use :
  • ,
  • NRFit-formatted protective cap :
  • ,
  • Scarifier :
  • ,
  • ENFit-formatted protective cap :
  • ,
  • Solid-seat mobile patient lifting system seat :
  • ,
  • ENFit oral/enteral syringe single-use :
  • ,
  • Vial/bottle adaptor non-hermetic :
  • ,
  • Fluid transfer tube general-purpose :
  • ,
  • Syringe tip cap :
  • ,
  • Surgical instrument/endoscope cleaning utensil single-use :
  • ,
  • Nasogastric tube holder noninvasive :
  • ,
  • Gastric drainage/decompression bag :
  • ,
  • Patient transfer/turning sheet :
  • ,
  • Breast-contact infant feeding tube :
  • ,
  • Gastric drainage/decompression bag :
  • ,
  • Patient transfer/turning sheet :
  • ,
  • Enteral tube extension sterile :
  • ,
  • Patient transfer system powered :
  • ,
  • Positive pressure airway secretion-clearing device :
  • ,
  • Rectal medication applicator single-use :
  • ,
  • Medication transfer needle filtering :
  • ,
  • Medication transfer straw :
  • ,
  • Air-filled chair cushion :
  • ,
  • Patient transfer sliding board :
  • ,
  • Gastric pH IVD kit colorimetric rapid :
  • ,
  • Gastric pH IVD kit colorimetric rapid :
GC UNITED KINGDOM LIMITED16-23 Coopers Court

Newport Pagnell
Buckinghamshire MK16 8JS

United Kingdom







04/15/202210727
  • Glass ionomer dental cement :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental porcelain/ceramic restoration kit :
  • ,
  • Composite dental impression material :
  • ,
  • Wax dental impression material :
  • ,
  • Alginate dental impression material :
  • ,
  • Dental impression tray material :
  • ,
  • Medical device cleaning sponge/set :
  • ,
  • Dappen dish single-use :
  • ,
  • Instrument tray liner :
  • ,
  • Instrument tray single-use :
  • ,
  • Dappen dish holder :
  • ,
  • Dental photo-activated disinfection system handpiece light guide :
  • ,
  • Dental impression material syringe reusable :
  • ,
  • Dental impression tray single-use :
  • ,
  • Dental shaded pontic kit :
  • ,
  • Dental prosthesis-component adhesive :
  • ,
  • Instrument transport trolley system :
  • ,
  • Dental implantation depth/angle gauge reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Dental torque wrench :
  • ,
  • Dental implant system :
  • ,
  • Dental implant abutment impression cap :
  • ,
  • Dental torque wrench adaptor :
  • ,
  • Dental implant holding endpiece :
  • ,
  • Bone tap reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant analog :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Dental drill bit extension :
  • ,
  • Dental implant system :
  • ,
  • Dental implant suprastructure permanent preformed :
  • ,
  • Dental implant holding endpiece :
  • ,
  • Dental implant suprastructure temporary preformed single-use :
  • ,
  • Screw endosteal dental implant two-piece :
  • ,
  • Orthodontic tube :
  • ,
  • Orthodontic spring :
  • ,
  • Orthodontic retainer :
  • ,
  • Orthodontic clasp metal preformed :
  • ,
  • Orthodontic metal band :
  • ,
  • Orthodontic face bow :
  • ,
  • Orthodontic archwire :
  • ,
  • Orthodontic appliance system bonded :
  • ,
  • Orthodontic bracket metal :
  • ,
  • Self-ligating orthodontic bracket :
  • ,
  • Orthodontic bracket ceramic :
  • ,
  • Orthodontic inter-bracket elastic chain :
  • ,
  • Orthodontic inter-arch elastic band :
  • ,
  • Orthodontic power arm/lock :
  • ,
  • Orthodontic separator :
  • ,
  • Orthodontic anchor plate :
  • ,
  • Orthodontic anchoring screw :
  • ,
  • Orthodontic archwire/bracket ligature :
  • ,
  • Orthodontic band material :
  • ,
  • Orthodontic wire :
  • ,
  • Composite dental impression material :
  • ,
  • Glass ionomer dental cement :
  • ,
  • Dental delivery system :
GCE s.r.o.Žižkova 381

Chotbo
583 01

Czechia

Gas Control Equipment LTDUK Responsible Person100 Empress Park Penny Lane
Haydock
St Helens
WA119DB
UK Responsible Person
United Kingdom
06/11/202115166
  • Vacuum suction regulator/regulation set general-purpose :
  • ,
  • Pneumatic suction regulator/regulation set :
  • ,
  • Oxygen therapy conserving regulator :
  • ,
  • Medical gas/vacuum pipeline system :
  • ,
  • Pulmonary resuscitator pneumatic reusable :
  • ,
  • Demand valve :
  • ,
  • General-gas low pressure tubing reusable :
  • ,
  • Non-heated respiratory humidifier :
  • ,
  • Medical air terminal unit :
  • ,
  • Medical gas flowmeter dial-type :
  • ,
  • Surgical suction system collection container reusable :
  • ,
  • Non-fixed medical gas cylinder regulator :
  • ,
  • Medical gas flowmeter Thorpe tube :
  • ,
  • Fixed medical gas cylinder regulator :
GCMEDICA ENTERPRISE LTD.(WUXI)Loujin Industrial Park

Wuxi
Jiangsu 214143

China

KINGSMEAD SERVICE LIMITEDUK Responsible Person19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
12/29/202120940
  • Surgical irrigation/aspiration tubing set :
  • ,
  • Airway suction catheter :
  • ,
  • Laryngeal mask airway single-use :
  • ,
  • Catheter orifice occluder :
  • ,
  • Surgical scrub brush single-use :
  • ,
  • Surgical tissue/fluid collection bag sterile :
  • ,
  • Fluid transfer set general-purpose :
  • ,
  • General-purpose surgical suction system vacuum :
  • ,
  • Simple pneumoperitoneum needle :
  • ,
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Oropharyngeal airway single-use :
  • ,
  • Spring-loaded pneumoperitoneum needle single-use :
  • ,
  • Bladder irrigation kit :
  • ,
  • Intrauterine curette suction :
  • ,
  • Low-pressure tubing connector single-use sterile :
  • ,
  • Scleral marker single-use :
  • ,
  • Surgical apron single-use :
  • ,
  • Gastrostomy tube :
  • ,
  • Oropharyngeal secretion specimen suction kit :
  • ,
  • Intravenous pressure infusor manual single-use :
  • ,
  • Catheter injection port :
  • ,
  • Endoscopic insufflation tubing set single-use :
  • ,
  • Medical equipment drape single-use :
GE BE Private Limites60 Export Promotion Industrial Park Whitefield

Bangalore
560066

India

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216573
  • X-ray tube housing assembly diagnostic :
GE BE PRIVATE LTD60 EXPORT PROMOTION INDUSTRIAL PARK WHITEFIELD

BANGALORE
560066

India

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216779
  • X-ray tube housing assembly diagnostic :
GE Hangwei Medical Systems Co LtdWest Area of Building N°3 N°1 Yongchang North Road Beijing Economic and Technological Area

Beijing
100176

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217170
  • Full-body CT system :
GE Hangwei Medical Systems CO. Ltd.West Area of Building N°3 N°1 Yongchang North Road Beijing Economic and Technological Development Area

Beijing
100176

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202219652
  • CT system application software :
GE Healthcare Austria GmbH & CO OG15 Tiefenbach

Zipf
4871

Austria

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216280
  • General-purpose ultrasound imaging system :
  • ,
  • General-purpose ultrasound imaging system :
  • ,
  • Extracorporeal ultrasound imaging transducer hand-held :
  • ,
  • Rectal/vaginal ultrasound imaging transducer :
  • ,
  • Ultrasound imaging system operation software :
GE Healthcare Coils a Division of USA Instruments Inc.1515 Danner DR

Aurora
44202

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217050
  • MRI system coil radio-frequency :
GE Healthcare Coils a division of USA Instruments Inc1515 Danner DR

Aurora
44202

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217434
  • MRI system coil radio-frequency :
  • ,
  • MRI system coil radio-frequency :
GE Healthcare Finland OYKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216742
  • Breathing circuit condensate trap reusable :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Patient monitoring system module blood pressure invasive :
  • ,
  • Patient monitoring system module carbon dioxide :
  • ,
  • Patient monitoring system module multifunction :
  • ,
  • Patient monitoring system module pulse oximetry :
  • ,
  • Patient monitoring system module cardiac output :
GE Healthcare Finland OYKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216915
  • Image display monitor colour :
  • ,
  • Patient monitoring system module rack :
  • ,
  • Breathing circuit gas-flow sensor reusable :
  • ,
  • Patient monitoring system module interfacing :
  • ,
  • Patient monitoring system module cardiac output :
GE Healthcare Finland OyKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216917
  • Analytical scalp electrode single-use :
  • ,
  • Pulse oximeter line-powered :
GE Healthcare Finland OyKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216920
  • Auditory stimulator :
GE Healthcare Finland OyKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216923
  • Analytical scalp lead :
GE Healthcare Finland OYKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216927
  • Patient monitoring system module multiple-gas :
GE Healthcare Finland OyKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216968
  • Patient monitoring system module electroencephalographic :
  • ,
  • Anaesthesia breathing circuit single-use :
  • ,
  • Centralized patient monitor :
  • ,
  • Haemodynamic monitoring system application software :
  • ,
  • Gas-sampling/monitoring respiratory tubing single-use :
  • ,
  • Bedside physiologic monitoring software :
  • ,
  • Neuromuscular transmission electrode :
  • ,
  • Neuromuscular transmission electrode/sensor lead :
  • ,
  • Neuromuscular transmission regional anaesthesia block adaptor :
  • ,
  • Neuromuscular transmission motion sensor :
  • ,
  • Neuromuscular transmission electrical skin sensor :
  • ,
  • Physiologic monitoring system alarm :
  • ,
  • Patient monitor remote control :
  • ,
  • Patient monitoring system module cardiac output :
GE Healthcare Finland OYKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
07/04/202225138
  • Noninvasive device battery charger :
  • ,
  • Personal device holder single-use :
  • ,
  • Thoracic electrical bioimpedance electrode array single-use :
  • ,
  • Electrode/transducer strap single-use :
  • ,
  • Pulse oximeter probe/processor :
  • ,
  • Multiple vital physiological parameter monitoring system transceiver :
  • ,
  • Respiration rate signal processor/transmitter :
GE Healthcare Finland OYKuortaneenkatu 2

Helsinki
FI-00510

Finland

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
07/14/202225253
  • General-purpose multi-parameter bedside monitor :
GE Healthcare GMBHBeethovenstr. 239

Solingen
42655

Germany

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216402
  • Medical image management system :
GE Healthcare IITS USA Corp also doing business as GE Healthcare500 W Monroe Street

Chicago
60661

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216961
  • Radiology PACS software :
  • ,
  • Radiology information system :
  • ,
  • Patient health record information system :
GE Healthcare Japan Corporation4-7-127 Asahigaoka Hino-Shi

Tokyo
191-8503

Japan

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216330
  • CT system application software :
  • ,
  • Full-body CT system :
  • ,
  • Extracorporeal ultrasound imaging transducer hand-held :
  • ,
  • Surgical ultrasound imaging transducer :
  • ,
  • Rectal/vaginal ultrasound imaging transducer :
GE Healthcare Japan Corporation7-127 Asahigaoka 4 chome Hino-Shi

Tokyo
8503

Japan

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217370
  • Full-body CT system :
GE Healthcare Japan Corporation7-127 Asahigaoka 4-chome Hino-Shi

Tokyo
191-8503

Japan

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217455
  • Needle guide reusable :
  • ,
  • Needle guide reusable :
GE Healthcare Japan Corporation7-127 Asahigaoka 4-chome Hino-Shi

Tokyo
191-8503

Japan

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217765
  • Full-body CT system :
GE Healthcare Tianjin Company LimitedN°266 Jingsan Road Tianjin Airport Economic Area

Tianjin
300308

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217244
  • Full-body MRI system superconducting magnet :
GE Healthcare (Tianjin) Company Limited266 Jingsan Road Tianjin Airport Economic Area

Tianjin
300308

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216904
  • Full-body MRI system superconducting magnet :
GE Healthcare (Tianjin) Company Limited266 Jingsan Road Tianjin Airport Economic Area

Tianjin
300308

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216914
  • MRI system coil radio-frequency :
GE Healthcare (Tianjin) Company LimitedN°266 Jingsan Road Tianjin Airport Economic Area

Tianjin
300308

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217498
  • MRI system coil radio-frequency :
GE Hualun Medical Systems CO LTDN°1 Yong Chang North Road Beijing Economic Technological Development Zone

Beijing
100176

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217342
  • Stationary basic diagnostic x-ray system analogue :
GE Hualun Medical Systems Co LtdN°1 Yong Chang North Road Beijing Economic Technological Development Zone

Beijing
100176

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202220733
  • Stationary basic diagnostic x-ray system digital :
GE Hualun Medical Systems Co. LTDN°1 Yong Chang North Road Beijing Economic Technological Development Zone

Beijing
100176

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217174
  • Stationary angiographic x-ray system digital :
  • ,
  • Stationary basic diagnostic x-ray system digital :
  • ,
  • Mobile general-purpose fluoroscopic x-ray system digital :
  • ,
  • Stationary gamma camera system :
  • ,
  • Nuclear medicine system workstation :
GE Medical Systems Information Technologies Inc.9900 Innovation Drive

Wauwatosa
53226

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217029
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Patient monitoring system module rack :
  • ,
  • Paper chart recorder :
  • ,
  • Computer network router :
  • ,
  • Electrocardiographic lead set reusable :
GE Medical Systems Information Technologies Inc.9900 Innovation Drive

Wauwatosa
53226

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217419
  • Electrocardiograph professional multichannel :
GE Medical Systems Information Technologies Inc.8200 West Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202218986
  • Patient monitoring system module multifunction :
GE Medical Systems Information Technologies Inc.9900 Innovation Drive

Wauwatosa
53226

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202219193
  • Centralized patient monitor :
GE Medical Systems Information Technologies Inc.9900 Innovation Drive

Wauwatosa
53226

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202223340
  • Electrocardiograph professional multichannel :
GE Medical Systems Information Technologies Inc.9900 Innovation Drive

Wauwatosa
53226

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
07/01/202225132
  • Wireless patient monitor/sensor reporting software professional :
  • ,
  • Wireless patient monitor/sensor reporting software professional :
  • ,
  • Physiologic monitoring system alarm :
  • ,
  • Bedside information system application software :
GE Medical Systems Information Technologies INC8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216971
  • Electrocardiograph professional single-channel :
GE Medical Systems Information Technologies INC8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216972
  • Electrocardiograph professional single-channel :
  • ,
  • Electrocardiograph professional multichannel :
  • ,
  • Electrocardiographic lead set reusable :
GE Medical Systems Information Technologies INC8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216974
  • Cardiac catheterization monitoring system :
GE Medical Systems Information Technologies INC8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216984
  • Electrocardiograph professional multichannel :
  • ,
  • Electrocardiographic long-term ambulatory recording analyser :
  • ,
  • Cardiology information system application software :
  • ,
  • Electrocardiographic lead set reusable :
GE Medical Systems Information Technologies INC8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216987
  • Blood pressure cuff reusable :
GE Medical Systems Information Technologies INC8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216995
  • Blood pressure cuff inflator manual :
  • ,
  • Blood pressure cuff inflator manual :
  • ,
  • Blood pressure cuff reusable :
  • ,
  • Blood pressure cuff reusable :
GE Medical Systems Information Technologies INC8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217011
  • Electrocardiography telemetric monitoring system :
  • ,
  • General-purpose multi-parameter bedside monitor :
  • ,
  • Patient monitoring system module multifunction :
  • ,
  • Computer network router :
  • ,
  • Multiple vital physiological parameter monitoring system clinical :
  • ,
  • Centralized patient monitor :
GE Medical Systems Information Technologies INC9900 Innovation Drive
9900 Innovation Drive
Wauwatosa
53226

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217290
  • Multiple vital physiological parameter monitoring system clinical :
  • ,
  • Patient monitoring system module blood pressure invasive :
  • ,
  • Patient monitoring system module pulse oximetry :
  • ,
  • Patient monitoring system module electrocardiographic/respiratory :
  • ,
  • Patient monitoring system module temperature :
GE Medical Systems Information Technologies Inc8200 W Tower Avenue

Milwaukee
53223

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217843
  • Centralized patient monitor :
GE Medical Systems Israel Functional Imaging4 Hayozma Street

Tirat Hacarmel
30200

Israel

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217188
  • Nuclear medicine system workstation :
  • ,
  • Stationary gamma camera system :
  • ,
  • Stationary gamma camera system :
  • ,
  • PET system :
  • ,
  • SPECT system application software :
GE Medical Systems Israel Functional Imaging4 Hayozma Street

Tirat Hacarmel
30200

Israel

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202219383
  • Stationary gamma camera system :
  • ,
  • Full-body CT system :
GE Medical Systems Israel Functional Imaging4 Hayozma Street

Tirat Hacarmel
30200

Israel

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202222210
  • Stationary gamma camera system :
GE Medical Systems LLC3000 N Grandview Blvd

Waukesha
Wisconsin 53188

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216319
  • Full-body CT system :
  • ,
  • Mobile basic diagnostic x-ray system digital :
  • ,
  • CT system application software :
  • ,
  • PET system application software :
  • ,
  • X-ray image interpretive software :
GE Medical Systems LLC4855 W Electric Avenue

Milwaukee
53219-1628

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216781
  • X-ray tube housing assembly diagnostic :
GE Medical Systems LLC3000 N Grandview Blvd

Waukesha
53188

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217143
  • Full-body MRI system superconducting magnet :
  • ,
  • MRI system coil radio-frequency :
  • ,
  • MRI system synchronizer :
  • ,
  • MRI image enhancement padding :
GE Medical Systems LLC3000 W Grandview Blvd

Waukesha
53188

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217243
  • Full-body MRI system superconducting magnet :
  • ,
  • MRI system application software :
  • ,
  • Full-body MRI system superconducting magnet :
  • ,
  • Full-body MRI system superconducting magnet :
  • ,
  • MRI system coil radio-frequency :
  • ,
  • MRI system coil radio-frequency :
GE Medical Systems LLC3200 North Grandview Blvd

Waukesha
53188

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217609
  • MRI system synchronizer :
  • ,
  • MRI image enhancement padding :
  • ,
  • Full-body MRI system superconducting magnet :
  • ,
  • MRI system application software :
  • ,
  • MRI system coil radio-frequency :
  • ,
  • MRI system coil radio-frequency :
  • ,
  • Full-body MRI system superconducting magnet :
GE Medical Systems LLC3200 North Grandview Blvd

Waukesha
53188

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217645
  • MRI system coil radio-frequency :
GE Medical Systems LLC3200 N. Grandview Blvd.

Waukesha
53188

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202221582
  • Full-body MRI system superconducting magnet :
GE Medical Systems SCS283 RUE DE LA MINIERE

BUC
78583

France

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/27/202213819
  • Diagnostic x-ray system generator stationary :
  • ,
  • Stationary angiographic x-ray system digital :
  • ,
  • Stationary mammographic x-ray system digital :
  • ,
  • CT system application software :
  • ,
  • PET system application software :
  • ,
  • MRI system application software :
  • ,
  • Diagnostic x-ray digital imaging system workstation :
  • ,
  • Radiology picture archiving and communication system workstation :
  • ,
  • Radiology PACS software :
  • ,
  • X-ray tube housing assembly diagnostic :
  • ,
  • Foot-switch electrical :
  • ,
  • Mammographic x-ray system stereotactic unit :
GE Medical Systems SCS8 Place de L'Hopital

Strasbourg
67000

France

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216546
  • Patient health record information system :
GE Medical Systems SCS283 RUE DE LA MINIERE

BUC
78530

France

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216698
  • X-ray tube housing assembly diagnostic :
GE Medical Systems SCS283 Rue de la Miniere

BUC
78530

France

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202219539
  • Stationary angiographic x-ray system digital :
GE Medical Systems SCS283 Rue de la Miniere

BUC
78530

France

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/28/202224399
  • Diagnostic x-ray digital imaging system workstation : Diagnostic x-ray digital imaging system workstation Conformity Assessment Certificate Expired
  • ,
  • Stationary angiographic x-ray system digital :
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC9900 Innovation Drive

Wauwatosa
53226

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217476
  • General-purpose ultrasound imaging system :
  • ,
  • Breast ultrasound imaging system :
  • ,
  • Extracorporeal ultrasound imaging transducer hand-held :
  • ,
  • Radiology PACS software :
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC3030 Ohmeda Dr

Madison
53718

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217155
  • Bone absorptiometric x-ray system dual-energy :
GE Medical Systems (China) CO LtdN°19 Changjiang Road Wuxi National Hi-Tech Dev. Zone

Jiangsu
214028

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217403
  • Electrocardiographic lead switching adaptor :
GE Medical Systems (China) CO LTDN° 19 Changjiang Road Wuxi Nationa Hi-Tech Dev. Zone

Jiangsu
214028

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217477
  • Cardiovascular ultrasound imaging system :
  • ,
  • General-purpose ultrasound imaging system :
GE Medical Systems (China) CO LtdN°19 Changjiang Road Wuxi National Hi-Tech Dev. Zone

Jiangsu
214028

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217683
  • Bone absorptiometric ultrasound system :
  • ,
  • Cardiovascular ultrasound imaging system :
GE Medical Systems (China) Co. Ltd.19 Changjiang Road Wuxi National Hi-Tech Dev. Zone

Jiangsu
214028

China

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216896
  • Anaesthesia workstation general-purpose :
  • ,
  • General-purpose ultrasound imaging system :
  • ,
  • Extracorporeal ultrasound imaging transducer hand-held :
GE OEC Medical Systems Inc.384 Wright Brothers Drive

Salt Lake City
84116

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202217055
  • Mobile general-purpose fluoroscopic x-ray system digital :
GE Parallel Design Inc4313 E Cotton Center Blvd Suite 100

Phoenix
85040

United States

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216617
  • Extracorporeal ultrasound imaging transducer hand-held :
GE Ultrasound Korea LTD9 Sunhwan-ro 214 Beon-gil Jungwon-gu Seongnam-si

Gyeonggi-do
13204

South Korea

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216655
  • General-purpose ultrasound imaging system :
GE Ultrasound Korea Ltd9 Sunhwan-ro 214beon-gil

Gyeonggi-do
13204

South Korea

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
06/13/202224933
  • General-purpose ultrasound imaging system :
GE Vingmed Ultrasound ASStrandpromenaden 45

Horten
3191

Norway

GE Medical Systems LimitedUK Responsible PersonPollards Wood Nightingales Lane Buckinghamshire

Chalfont St Giles
HP8 4SP
UK Responsible Person
England United Kingdom
04/15/202216299
  • Oesophageal ultrasound imaging transducer reusable :
  • ,
  • General-purpose ultrasound imaging system :
  • ,
  • Cardiovascular ultrasound imaging system :
  • ,
  • Extracorporeal ultrasound imaging transducer hand-held :
  • ,
  • Hand-held ultrasound imaging system body-surface :
  • ,
  • Ultrasound imaging system application software :
Gebauer Medizintechnik GMBHMonbachstrasse 7/1

75242 Neuhausen
75242

Germany

Eye Spy Products LtdUK Responsible Person6 Priory Close Worsbrough Village

Barnsley
South Yorkshire S70 5LX
UK Responsible Person
England United Kingdom
07/09/202115667
  • Cultured skin autograft/xenograft :
gebdi DENTAL-PRODUCTS GmbHIndustriestraße 3a

Engen
78234

Germany

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
07/13/202217735
  • Partial denture :
Gebrüder Martin GmbH & Co. KGKLS Martin Platz 1

Tuttlingen
78532

Germany

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
05/18/202114745
  • Wrist ulna-head prosthesis :
  • ,
  • Orthopaedic bone wire :
  • ,
  • Craniofacial bone screw non-bioabsorbable sterile :
  • ,
  • Craniofacial bone tack bioabsorbable :
  • ,
  • Craniofacial bone screw non-bioabsorbable sterile :
  • ,
  • Craniofacial fixation plate bioabsorbable :
  • ,
  • Craniofacial fixation plate non-bioabsorbable :
  • ,
  • Craniofacial fixation plate non-bioabsorbable :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable sterile :
  • ,
  • Implantable craniofacial bone distractor :
  • ,
  • Temporary mandibular condyle prosthesis :
  • ,
  • Custom-made cranial bone prosthesis :
  • ,
  • Custom-made cranial bone prosthesis mould :
  • ,
  • Proximal interphalangeal joint prosthesis modular :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
  • ,
  • Orthopaedic fixation plate non-bioabsorbable non-sterile :
  • ,
  • Orthopaedic bone washer non-sterile :
  • ,
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
  • ,
  • Custom-made orthopaedic/craniofacial surgical guide :
  • ,
  • Surgical power tool system handpiece rotary non-rechargeable battery-powered reusable :
  • ,
  • Disposable battery pack :
  • ,
  • Body aspiration needle reusable :
  • ,
  • Surgical irrigation/aspiration cannula non-illuminating reusable :
  • ,
  • Surgical instrument guard reusable :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Orthopaedic bur single-use :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Orthopaedic bur single-use :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Orthopaedic trocar blade reusable :
  • ,
  • Bone pin ultrasonic osteosynthesis system :
  • ,
  • Bone pin ultrasonic osteosynthesis system handpiece :
  • ,
  • Bone pin ultrasonic osteosynthesis system sonotrode tip :
  • ,
  • Bone pin ultrasonic osteosynthesis system sonotrode tip :
  • ,
  • Surgical implant template single-use :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • ENT suction dissector :
  • ,
  • Liposuction system cannula reusable :
  • ,
  • Electrosurgical system generator :
  • ,
  • General/multiple surgical solid-state/carbon dioxide laser system :
  • ,
  • General/multiple surgical solid-state/carbon dioxide laser system :
  • ,
  • Endoscopic electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Argon-enhanced electrosurgical system generator :
  • ,
  • Argon-enhanced electrosurgical system generator :
  • ,
  • Laser adaptor :
  • ,
  • Manual scalpel blade single-use :
  • ,
  • Surgical plume evacuation system :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Laser beam delivery unit holder :
  • ,
  • Laser beam delivery unit holder :
  • ,
  • Dermatological laser beam guiding handpiece :
  • ,
  • Varicose vein lasing procedure kit :
  • ,
  • Open-surgery electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • General/multiple surgical diode laser system :
  • ,
  • General/multiple surgical laser system beam guide reusable :
  • ,
  • General/multiple surgical laser system beam guide reusable :
  • ,
  • Open-surgery electrosurgical electrode monopolar reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Intrauterine curette suction :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • General/multiple surgical solid-state/carbon dioxide laser system :
  • ,
  • Orthopaedic chisel :
  • ,
  • Umbilical cord clamp reusable :
  • ,
  • Mitral valve dilator :
  • ,
  • Common bile duct dilator :
  • ,
  • Tracheal surgery dilator reusable :
  • ,
  • Amniotome reusable :
  • ,
  • Vaginal dilator :
  • ,
  • Fingernail drill bit :
  • ,
  • Open-surgery biopsy forceps reusable :
  • ,
  • Intrauterine device removal hook reusable :
  • ,
  • Scalpel handle reusable :
  • ,
  • Ear knife :
  • ,
  • Tonsil knife :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Orthopaedic osteotome :
  • ,
  • Plastic surgery osteotome :
  • ,
  • Pelvimeter :
  • ,
  • Middle ear pick :
  • ,
  • Hand-held dental retractor :
  • ,
  • Intraocular scissors conventional-hinge reusable :
  • ,
  • Neurosurgical scissors :
  • ,
  • Nasal scissors :
  • ,
  • Rectal scissors :
  • ,
  • Suture scissors :
  • ,
  • Bone trephine :
  • ,
  • Urethral bougie reusable :
  • ,
  • Nasal snare reusable :
  • ,
  • Tonsil scissors :
  • ,
  • Bone tap reusable :
  • ,
  • Vessel approximator :
  • ,
  • Manual bone mill :
  • ,
  • Airway tube forceps reusable :
  • ,
  • Dental articulation paper forceps :
  • ,
  • Dental dressing forceps reusable :
  • ,
  • Dental surgical scissors :
  • ,
  • General-purpose calliper metallic :
  • ,
  • Surgical mallet :
  • ,
  • Suturing needle reusable :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Intrauterine curette manual :
  • ,
  • Orthopaedic bone pin non-bioabsorbable :
  • ,
  • Orthopaedic implant impactor :
  • ,
  • Wire/ligature passer reusable :
  • ,
  • Wire cutter :
  • ,
  • Wire holding/twisting forceps :
  • ,
  • Orthodontic pliers :
  • ,
  • ENT wire-cutting scissors :
  • ,
  • Ear scissors reusable :
  • ,
  • ENT probe reusable :
  • ,
  • Craniofacial rongeur reusable :
  • ,
  • Bone hook :
  • ,
  • Periocular/lacrimal retractor hand-held reusable :
  • ,
  • Gynaecological scissors reusable :
  • ,
  • Cytology scraper reusable :
  • ,
  • Dura mater dissector :
  • ,
  • Brain spatula :
  • ,
  • Lung spatula :
  • ,
  • Vein stripper reusable :
  • ,
  • Spinal rongeur :
  • ,
  • Tooth extraction forceps :
  • ,
  • Uterine depressor :
  • ,
  • Nail extraction forceps :
  • ,
  • Vascular scissors :
  • ,
  • Surgical flat-nosed pliers :
  • ,
  • Joint prosthesis implantation kit reusable :
  • ,
  • Orthopaedic implantable-device cutter :
  • ,
  • Periodontal file/rasp manual :
  • ,
  • Ear canal irrigation syringe :
  • ,
  • ENT elevator :
  • ,
  • Bone lever/elevator reusable :
  • ,
  • Open-surgery stone-retrieval forceps :
  • ,
  • Surgical gouge :
  • ,
  • Amputation knife :
  • ,
  • Cast/plaster knife :
  • ,
  • Scalpel reusable :
  • ,
  • Fistula probe :
  • ,
  • Aorta punch reusable :
  • ,
  • Nasal file/rasp :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Ligation clip metallic :
  • ,
  • Orthopaedic cerclage applier :
  • ,
  • Open-surgery ligation clip applier :
  • ,
  • Surgical penis clamp reusable :
  • ,
  • Dental excavator reusable :
  • ,
  • Rubber dam clamp forceps :
  • ,
  • Myoma screw reusable :
  • ,
  • Vascular graft tunneller :
  • ,
  • Dental anaesthesia syringe reusable :
  • ,
  • Haemostatic knife :
  • ,
  • Manual surgical rotary handpiece reusable :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Abdominal/intestinal spatula :
  • ,
  • Blood lancet reusable :
  • ,
  • Razor blade :
  • ,
  • Nasal knife :
  • ,
  • Laryngeal knife :
  • ,
  • Surgical vice grip :
  • ,
  • Dermatome handle :
  • ,
  • General-purpose surgical spatula :
  • ,
  • Periodontal knife :
  • ,
  • Dental restoration carver resin :
  • ,
  • Clamp manipulation forceps :
  • ,
  • Tendon stripper :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Dental osteotome :
  • ,
  • Razor blade breaker/holder :
  • ,
  • Manual surgical saw blade rigid :
  • ,
  • Manual surgical saw flexible :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • Periotome reusable :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Bone cutting forceps :
  • ,
  • Bone holding forceps :
  • ,
  • Fibreoptic retractor handle :
  • ,
  • Surgical retractor/retraction system blade reusable :
  • ,
  • Intrauterine scoop :
  • ,
  • Scalp wound clip :
  • ,
  • Orthopaedic trocar blade reusable :
  • ,
  • Endaural surgical curette reusable :
  • ,
  • Paranasal sinus curette :
  • ,
  • Implantable craniofacial bone distractor :
  • ,
  • Implantable craniofacial bone distractor :
  • ,
  • Bone fixation plate pliers :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Surgical bulldog clamp reusable :
  • ,
  • Periodontal curette :
  • ,
  • Suturing unit reusable :
  • ,
  • Laser fibre cleaving tool :
  • ,
  • Laser fibre stripper :
  • ,
  • Surgical plume evacuation system :
  • ,
  • Endoscopic electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Dressing/utility forceps scissors-like reusable :
  • ,
  • Dental elevator tooth/root :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Enucleation scissors :
  • ,
  • Gallstone scoop :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Surgical implant handling forceps :
  • ,
  • General utility supply system ceiling-mounted :
  • ,
  • General utility supply system ceiling-mounted :
  • ,
  • Manual scalpel blade single-use :
  • ,
  • Surgical implant template reusable :
  • ,
  • Bone-coring punch reusable :
  • ,
  • Fluted surgical drill bit single-use :
  • ,
  • Surgical implant template reusable :
  • ,
  • Temporary mandibular condyle prosthesis :
  • ,
  • Surgical instrument guard reusable :
  • ,
  • Surgical screwdriver reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Bone awl reusable :
  • ,
  • Periosteal elevator reusable :
  • ,
  • Bone curette reusable :
  • ,
  • Open-surgery dissector :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Nerve/vessel retractor :
  • ,
  • Implantable craniofacial bone distractor :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Electrosurgical cable adaptor :
  • ,
  • Operating table accessory trolley :
  • ,
  • Foot-switch electrical :
Gebr. Brasseler GmbH & Co. KGTrophagener Weg 25

Lemgo
32657

Germany

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
10/05/202117982
  • Cranial bur reusable :
  • ,
  • Cranial bur reusable :
  • ,
  • Podiatric bur reusable :
  • ,
  • Carbide dental bur reusable :
  • ,
  • Steel dental bur reusable :
  • ,
  • Steel dental bur reusable :
  • ,
  • Dental abrasive point reusable :
  • ,
  • Manual endodontic file/rasp reusable :
  • ,
  • Dental mandrel :
  • ,
  • Endodontic broach serrated reusable :
  • ,
  • Endodontic broach serrated reusable :
  • ,
  • Dental abrasive disk reusable :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Orthopaedic bur reusable :
  • ,
  • Root canal post preformed :
  • ,
  • Rotary/reciprocating endodontic file/rasp reusable :
  • ,
  • Rotary/reciprocating endodontic file/rasp reusable :
  • ,
  • Pin/post dental drill bit :
  • ,
  • Pin/post dental drill bit :
  • ,
  • Sternum saw blade single-use :
  • ,
  • Pneumatic dental scaling/debridement system handpiece tip periodontal reusable :
  • ,
  • Pneumatic dental scaling/debridement system handpiece tip periodontal reusable :
  • ,
  • Sternum saw blade reusable :
  • ,
  • Sternum saw blade reusable :
  • ,
  • Orthopaedic bur single-use :
  • ,
  • Dental power tool converter attachment non-rotary :
  • ,
  • Dental power tool converter attachment non-rotary :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Fixture/appliance dental drill bit reusable :
  • ,
  • Intraoperative bone pin/screw non-sterile :
  • ,
  • Dental power tool converter attachment rotary :
  • ,
  • Ceramic dental bur :
  • ,
  • Ceramic dental bur :
  • ,
  • Bone file/rasp reciprocating single-use :
  • ,
  • Dental-professional prophylaxis brush single-use :
  • ,
  • Pneumatic dental scaling/debridement system handpiece tip endodontic reusable :
  • ,
  • Pneumatic dental scaling/debridement system handpiece tip endodontic reusable :
  • ,
  • Pneumatic dental power tool system handpiece tip reusable :
  • ,
  • Pneumatic dental power tool system handpiece tip reusable :
  • ,
  • Sterilizer/disinfector rack instrument-holding insert reusable :
  • ,
  • Steel dental bur reusable :
  • ,
  • Surgical saw blade sagittal reusable :
  • ,
  • Surgical saw blade sagittal reusable :
  • ,
  • Surgical saw blade reciprocating reusable :
  • ,
  • Surgical saw blade reciprocating reusable :
  • ,
  • Carbide dental bur reusable :
  • ,
  • Surgical saw blade sagittal single-use :
  • ,
  • Surgical saw blade reciprocating single-use :
  • ,
  • Rotary/reciprocating endodontic file/rasp single-use :
  • ,
  • Dental abrasive strip reusable :
  • ,
  • Sterilizer/disinfector rack :
  • ,
  • Diamond dental bur reusable :
  • ,
  • Diamond dental bur reusable :
  • ,
  • Carbide dental bur single-use :
Geister Medizintechnik GmbHFOHRENSTRABE 2

TUTTLINGEN
78532

Germany

Emmat Medical LtdUK Responsible PersonUnit 5A-5B Newton Court Westrand Pendeford Business Park

Wolverhampton
West Midlands WV9 5HB
UK Responsible Person
United Kingdom
07/23/202116184
  • Laparoscopic dilation guide rod :
  • ,
  • Surgical bulldog clamp reusable :
  • ,
  • Surgical power tool system handpiece sawing rechargeable battery-powered :
  • ,
  • Laparoscopic surgical procedure kit non-medicated reusable :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • Head-worn lamp :
  • ,
  • Vascular dilator reusable :
  • ,
  • Vein stripper reusable :
  • ,
  • Valvulotome :
  • ,
  • General-purpose bowl reusable :
  • ,
  • Surgical A/V-shaped microvessel clamp :
  • ,
  • Sharp surgical instrument counting tray/pad reusable :
  • ,
  • Tunnelling forceps :
  • ,
  • General/plastic surgery mirror :
  • ,
  • Scalpel handle reusable :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Obstetrical forceps reusable :
  • ,
  • Manual surgical saw rigid :
  • ,
  • Skin marking pen reusable :
  • ,
  • Crown surgical drill bit reusable :
  • ,
  • Neurosurgical probe :
  • ,
  • Vaginal speculum reusable :
  • ,
  • Suture knot-tying device :
  • ,
  • Surgical camera holder :
  • ,
  • Self-retaining surgical retractor reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Surgical gastrointestinal clamp :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Orthopaedic instrument surgical connector :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Clamp manipulation forceps :
  • ,
  • Spinal rongeur :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Suturing needle holder reusable :
  • ,
  • General-purpose surgical scissors reusable :
Geistlich Pharma AGBahnhofstrasse 40

Wolhusen
6110

Switzerland

Geistlich Sons LimitedUK Responsible PersonThorley House Bailey lane
Manchester Airport Manchester
Manchester
M90 4AB
UK Responsible Person
United Kingdom
01/08/202111462
  • Collagen dental regeneration membrane :
  • ,
  • Cartilage repair membrane :
  • ,
  • Vascular catheter/cannula flush solution anticoagulant antimicrobial :
  • ,
  • Bone matrix implant animal-derived bioabsorbable :
  • ,
  • Dental bone matrix implant animal-derived :
  • ,
  • Dental soft-tissue matrix implant animal-derived : Dental soft-tissue matrix implant animal-derived Conformity Assessment Certificate Expired
  • ,
  • Dental soft-tissue matrix implant animal-derived :
Gel Ovations Europe LimitedCharlton Road

Bristol
Gloucestershire BS10 6NF

England United Kingdom







04/13/20229329
  • Wheelchair armrest :
  • ,
  • Crutch pad :
  • ,
  • Wheelchair footrest :
  • ,
  • Wheelchair bracket :
  • ,
  • Wheelchair headrest :
  • ,
  • Gel-filled chair cushion :
  • ,
  • Limb/torso/head restraint reusable :
  • ,
  • Medical cushion cover :
  • ,
  • Wheelchair legrest pad :
GELITA MEDICAL GmbHUferstraße 7

Eberbach
69412

Germany

Delta Surgical LimitedUK Responsible PersonUnit 10 Evolution Lymedale Business Park

Newcastle under Lyme
Staffordshire ST5 9QF
UK Responsible Person
United Kingdom
03/23/202112813
  • Plant polysaccharide haemostatic agent bioabsorbable :
  • ,
  • Gelatin haemostatic agent :
GelPacks Direct LtdSuite 2a Blackthorn House Mary Ann Street
St Pauls Square
Birmingham
B3 1RL

England United Kingdom
0121 369 1239
info@gelpacksdirect.co.uk






04/07/20224439
  • Hot/cold therapy pack reusable :
GEM S.r.lVia dei Campi 2
VIAREGGIO
Viareggio
Toscana 55049

Italy

Selamedical UK LtdUK Responsible PersonBuilding 4 North London Business Park Oakleigh Road South
London
London
N11 1GN
UK Responsible Person
England United Kingdom
03/21/202212879
  • Surgical internal adhesive/sealant synthetic polymer :
  • ,
  • Skin-approximation adhesive :
  • ,
  • Atomizing surgical adhesive/sealant applicator :
  • ,
  • Dermal surgical adhesive/sealant applicator :
  • ,
  • Laparoscopic surgical adhesive/sealant catheter :
  • ,
  • Open-surgery adhesive/sealant applicator single-channel :
  • ,
  • Arterial catheterization surgical adhesive/sealant applicator :
Gemma Medical AGMattenstrasse 11

Bruegg
CH-2555

Switzerland

Vision Matrix LtdUK Responsible PersonVision Matrix Ltd 31 East Parade

Harrogate
North Yorkshire HG1 5LQ
UK Responsible Person
England United Kingdom
04/19/202213632
  • Intraocular retractor single-use :
  • ,
  • Eyelid speculum single-use :
  • ,
  • Ocular hook/spatula/manipulator single-use :
  • ,
  • Ophthalmic soft-tissue manipulation forceps tweezers-like single-use :
  • ,
  • Ophthalmic surgical device handling forceps :
  • ,
  • Ophthalmic implant handling forceps single-use :
Gemtier Medical (Shanghai) Inc.No.18 Jianding Road Fengjing Town Jinshan District

Shanghai
201502

China

CMC Medical Devices LTDUK Responsible PersonOffice 32 19-21 Crawford Street

London
W1H 1PJ
UK Responsible Person
United Kingdom
10/25/202118427
  • General-purpose syringe single-use :
  • ,
  • Hypodermic needle single-use :
  • ,
  • General-purpose syringe/needle :
  • ,
  • Blood collection set invasive :
  • ,
  • Surgical/medical face mask single-use :
Genbody Inc3-18 Eopseong 2-gil
Seobuk-gu Cheonan-si
Chungcheongnam-do
312-800

South Korea

Phil and Adams LimitedUK Responsible Person2 Mannin Way

Lancaster
LA1 3SU
UK Responsible Person
United Kingdom
02/04/202211971
  • SARS-CoV-2 antigen IVD kit fluorescent immunoassay rapid :
Genea Biomedx Pty LtdLevel 2 321 Kent Street

Sydney
NSW 2000

Australia

Donawa Lifescience LtdUK Responsible PersonAviation Business Park Enterprise Close

Christchurch
BH23 6NX
UK Responsible Person
England United Kingdom
05/05/202114394
  • Assisted reproduction incubator/microscope camera system :
  • ,
  • Assisted reproduction embryo-assessment software :
  • ,
  • Assisted reproduction specimen management system :
  • ,
  • Assisted reproduction vitrification carrier :
  • ,
  • Assisted reproduction vitrification kit :
  • ,
  • Assisted reproduction procedure dish :
  • ,
  • Intravenous/irrigation solution storage container single-use :
  • ,
  • IVF medium :
Genedrive Diagnostics48 Grafton Street

Manchester
M139XX

United Kingdom







11/26/20199327
  • Mitochondrial genetic disorder IVD kit nucleic acid technique (NAT) :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory semi-automated :
  • ,
  • Laboratory instrument/analyser application software IVD :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
  • ,
  • Mitochondrial genetic disorder IVD control :
  • ,
  • Thermal cycler nucleic acid amplification analyser IVD laboratory automated :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT) :
GeneFirst LimitedUnit 2 The Quadrant Abingdon Science Park
Abingdon
Oxfordshire
OX14 3YS

England United Kingdom







10/14/20166313
  • Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type respiratory pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
GeneProof a.s.101/119 Dolní Heršpice
Vídeská Brno
Brno-msto
Jihomoravský kraj 619 00

Czechia

Pathway Diagnostics LtdUK Responsible PersonEclipse House Curtis Road

Dorking
Surrey RH4 1EJ
UK Responsible Person
United Kingdom
05/19/202224319
  • Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • HIV1 genotyping IVD kit nucleic acid technique (NAT) :
  • ,
  • Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Chlamydia pneumoniae nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Epstein-Barr virus (EBV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple immunocompromised host infection-associated virus nucleic acid IVD nucleic acid technique (NAT) :
  • ,
  • Adenovirus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Aspergillus fumigatus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Human herpesvirus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human herpesvirus 8 (HHV8) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Parvovirus B19 nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Varicella-zoster virus (VZV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Neisseria gonorrhoeae nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Mycoplasma species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Ureaplasma urealyticum nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Trichomonas vaginalis nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Treponema pallidum nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Borrelia burgdorferi nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Enterovirus nucleic acid (serotypes 68-71) IVD kit nucleic acid technique (NAT) :
  • ,
  • MRSA nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple human parainfluenza virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Bordetella species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Legionella pneumophila nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Mycoplasma pneumoniae nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Mycobacterium tuberculosis nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Coagulation factor II (prothrombin) mutation IVD kit nucleic acid technique (NAT) :
  • ,
  • Inherited thrombophilia IVD kit nucleic acid technique (NAT) :
  • ,
  • Coagulation factor XIII mutation IVD kit nucleic acid technique (NAT) :
  • ,
  • Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT) :
  • ,
  • Cardiovascular disease genetic risk IVD kit nucleic acid technique (NAT) :
  • ,
  • Plasminogen activator inhibitor 1 (PAI-1) mutation IVD kit nucleic acid technique (NAT) :
  • ,
  • PCR/NAT negative control IVD :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
General Biologicals CorporationNo.6 Innovation First Road Hsinchu Science Park
Baoshan Township Hsinchu County 30076
Taiwan R.O.C
30076

Taiwan

FREYR LIFE SCIENCES LTDUK Responsible Person9 Greyfriars Road

Reading
Berkshire RG1 1NU
UK Responsible Person
England United Kingdom
UKRP@FREYRSOLUTIONS.COM
11/01/202118725
  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus core total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis B virus surface antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Hepatitis C virus total antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • HIV1/HIV2 antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • General specimen collection kit IVD clinical :
General Life Biotechnology Co. Ltd.6 7F. No. 669 Jhongjheng Rd. Shin Juang Dist.

New Taipei City
242

Taiwan

MDSS-UK RP LIMITEDUK Responsible Person6 Wilmslow Road Rusholme

Manchester
M14 5TP
UK Responsible Person
England United Kingdom
01/24/202222172
  • Total cholesterol lipid IVD kit chemiluminescent immunoassay rapid :
  • ,
  • Haemoglobin detection IVD reagent :
  • ,
  • Haemoglobin detection IVD control :
  • ,
  • Haemoglobin analyser IVD home-use :
  • ,
  • Uric acid IVD reagent :
  • ,
  • Uric acid IVD control :
  • ,
  • Total cholesterol lipid IVD control :
  • ,
  • Glucose IVD control :
  • ,
  • Glucose IVD kit electrometry :
  • ,
  • Multiple clinical chemistry analyser IVD home-use :
  • ,
  • Glucose monitoring system IVD home-use :
  • ,
  • Glucose/ketone/lipid profile IVD control :
  • ,
  • Glucose/ketone monitoring system IVD home-use :
  • ,
  • Glucose/ketone/lipid profile IVD reagent :
General Medical Merate S.p.A.Via Partigiani 25

Seriate
BG 24068

Italy

QCS International LTD.UK Responsible PersonSuite 9 Cumbernauld Business Park
Wardpark Road
Cumbernauld
North Lanarkshire G67 3JZ
UK Responsible Person
Scotland United Kingdom
08/06/202116593
  • Stationary basic diagnostic x-ray system digital :
  • ,
  • X-ray system tube support ceiling mounted :
  • ,
  • X-ray system tube support floor standing :
GeneReach Biotechnology Corp.No.19 Keyuan 2nd Road
Xitun Dist.
Taichung City 407
407

Taiwan

HORIBA UK LimitedUK Responsible PersonKYOTO CLOSE MOULTON PARK

NORTHAMPTON
Northants NN3 6FL
UK Responsible Person
United Kingdom
04/15/202221707
  • Clostridium difficile nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Norovirus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Viral inactivation buffer IVD :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
  • ,
  • Nucleic acid sample preparation instrument IVD automated :
  • ,
  • SARS-CoV-1 antigen IVD reagent :
Genesee BioMedical Inc700 W. Mississippi Avenue Unit D5 Denver

Colorado
CO 80223-4509,

United States

Adveniunt Medical International Limited (trading as Quality First International)UK Responsible Person1 Cooks Road
Stratford
London
E15 2PW
UK Responsible Person
England United Kingdom
05/22/202010062
  • Electrical-only medical device connection cable reusable :
  • ,
  • Sternum spreader :
Genesis Dental Ceramics Ltd3 Court Street

Nottingham
Nottinghamshire NG7 5DT

United Kingdom







04/06/20223572
  • Dental Appliances/Prostheses :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Root canal post custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown metal/polymer :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Resin dental inlay :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
Genesis Dental Laboratory LtdGENESIS DENTAL LABORATORY LTD Lawes House
66-68 Bristol Road Portishead
Bristol
North Somerset BS20 6QG

United Kingdom







05/14/20154661
  • Bonded dental bridge :
  • ,
  • Ceramic dental inlay :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • 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 :
  • ,
  • Custom-made mouthguard :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental occlusal splint customizable :
  • ,
  • Dental occlusal splint preformed reusable :
  • ,
  • Dental veneer professional :
  • ,
  • Gold dental inlay :
  • ,
  • Mandible-repositioning sleep-disordered breathing orthosis :
  • ,
  • Orthodontic retainer :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Preformed complete denture :
  • ,
  • Preformed dental crown permanent :
  • ,
  • Preformed dental crown temporary :
  • ,
  • Resin dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Temporary dental crown/bridge :
Genetic Analysis ASKabelgata 8

Oslo
0580

Norway

BIOHIT HealthCare LtdUK Responsible PersonPioneer House Pioneer Business Park
North Road
Ellesmere Port
Cheshire CH65 1AD
UK Responsible Person
England United Kingdom
07/01/202225131
  • Human gut microbiome nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) :
Genetic Signatures Ltd7 Eliza St

Newtown
NSW 2042

Australia

Genetic Signatures (UK) LimitedUK Responsible PersonMarine House 151 Western Road

Haywards Heath
West Sussex RH16 3LH
UK Responsible Person
England United Kingdom
04/11/202224127
  • Multiple-type respiratory pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Escherichia coli nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type gastrointestinal pathogen nucleic acid IVD kit nucleic acid technique (NAT) :
Genimpex srlViale Lombardia 143

Brugherio
20861

Italy

FORTUNA HEALTHCARE LIMITEDUK Responsible PersonUNITS 3 - 4 Northgate Business Centre Crown Road
Enfield
London
EN11TG
UK Responsible Person
England United Kingdom
julian.bavetta@fortunahealthcare.com
05/12/202224560
  • Decontamination floor mat single-use :
  • ,
  • Decontamination floor mat single-use :
GENINCODE SLURambla d’Egara 235 5a planta C D

Terrassa
08224

Spain

GENinCode PLCUK Responsible PersonOne St. Peters Square

Manchester
Greater Manchester M2 3DE
UK Responsible Person
England United Kingdom
06/10/202115172
  • Familial hypercholesterolaemia IVD primer :
GenMark Diagnostics5964 La Place Ct

CARLSBAD
California 92008

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
12/02/202120282
  • Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple-type bloodstream pathogen nucleic acid IVD kit nucleic acid amplification/mass spectrometry :
  • ,
  • Nucleic acid sequence analyser IVD next-generation sequencing (NGS) :
  • ,
  • Multiple respiratory virus antigen IVD kit multiplex : Multiple respiratory virus antigen IVD kit multiplex Conformity Assessment Certificate Expired
Genmed Enterprises International LtdFountain House Fountain Lane

St. Mellons
Cardiff CF3 0FB

Wales United Kingdom







02/23/202223241
  • Laparoscopic access cannula single-use :
Genmed Enterprises LTD7/f Greenfield Tower Concordia Plaza
1 Science Museum Road Trimshatsui East
Hong Kong
999077

China

Genmed Enterprises UK LTDUK Responsible PersonFountain House Fountain Lane

Cardiff
St. Mellons CF3 0FB
UK Responsible Person
Wales United Kingdom
03/30/202112702
  • Laparoscopic access cannula single-use :
Genmed Enterprises Ltd7/f Greenfield Tower Concordia Plaza
1 Science Museum Road Trimshatsui East
Greenfield
Kowloon 999077

China

Genmed Enterprises UK LTDUK Responsible PersonFountain House Fountain Lane

Cardiff
St. Mellons CF3 0FB
UK Responsible Person
Wales United Kingdom
04/04/202113081
  • Surgical/emergency suction cannula non-illuminating single-use :
  • ,
  • Endoscopic electrosurgical handpiece/electrode monopolar single-use :
  • ,
  • Tissue extraction bag :
  • ,
  • Spring-loaded pneumoperitoneum needle single-use :
Genobio Pharmaceutical Co. Ltd2-1 2 3-101 No. 2 Zone Binlv Industrial Park
Binhai Tourism Area Binhai New Area
Tianjin
300480

China

BioConnections LtdUK Responsible PersonUnit 10 Brindley Court Victoria Business Park

Knypersley
Staffordshire ST8 7PP
UK Responsible Person
England United Kingdom
12/16/202120578
  • Magnetic particle immunoassay analyser IVD automated :
  • ,
  • Photometric/spectroscopic immunoassay analyser IVD :
  • ,
  • Cryptococcus complex species antigen IVD kit rapid ICT clinical :
  • ,
  • Cryptococcus neoformans antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • 13-Beta-D-glucan IVD kit enzyme immunoassay (EIA) :
  • ,
  • Lipopolyssacharide (LPS) IVD kit chemiluminescent immunoassay :
  • ,
  • Multiple Aspergillus species antigen IVD kit rapid ICT clinical :
  • ,
  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Aspergillus fumigatus immunoglobulin M (IgM) antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Aspergillus species antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Candida species mannan antigen IVD kit enzyme immunoassay (EIA) :
  • ,
  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Multiple Aspergillus species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Multiple Candida species nucleic acid IVD kit nucleic acid technique (NAT) :
  • ,
  • Reverse transcription reagent kit IVD :
Genome Diagnostics B.V.Yalelaan 48
Utrecht
Gemeente Utrecht
Utrecht 3584 CM

Netherlands

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
08/06/202116512
  • HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • Human genomic analysis interpretive software :
  • ,
  • HLA class I antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
  • ,
  • HLA class I & II antigen nucleic acid tissue typing IVD reagent :
  • ,
  • Human genomic analysis interpretive software IVD :
  • ,
  • HLA class I & II antigen nucleic acid tissue typing IVD kit nucleic acid technique (NAT) :
Genomic Health Inc.301 Penobscot Drive

Redwood City
California 94063

United States

Qarad UK Ltd.UK Responsible Person8 Northumberland Ave

Westminster
London WC2N 5BY
UK Responsible Person
England United Kingdom
01/20/202221391
  • Cancer-related multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT) :
  • ,
  • Cancer risk assessment interpretive software IVD :
  • ,
  • Nucleic acid extraction/isolation kit IVD :
Genomic Health Inc.301 Penobscot Drive

Redwood City
94063

United States

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
05/03/202224470
  • General tissue specimen container IVD no additive :
Genomics plcKing Charles House Park End Street

Oxford
OX1 1JD

England United Kingdom







07/26/202116415
  • Human genomic analysis interpretive software :
GENORAY Co. Ltd.(Sangdaewon-dong Byucksan Technopia) 512 560 Dunchon-daero Jungwon-gu Seongnam-si Gyeonggi-do Republic of Korea

Seongnam-si
Gyeonggi-do 13230

South Korea

Obelis UK LtdUK Responsible PersonSandford Gate East Point Business Park

Oxford
OX4 6LB
UK Responsible Person
England United Kingdom
05/05/202224519
  • Hand-held intraoral dental x-ray system digital :
  • ,
  • Stationary panoramic dental x-ray system digital :
  • ,
  • Dental digital imaging sensor intraoral :
  • ,
  • Stationary intraoral dental x-ray system digital :
  • ,
  • Stationary panoramic/tomographic dental x-ray system digital :
  • ,
  • Mobile general-purpose fluoroscopic x-ray system digital :
Genoss Co. Ltd.1F Gyeonggi R&DB Center / 226 2F GSBC 105 Gwanggyo-ro Yeongtong-gu

Suwon-si
Gyeonggi-do 443-270

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
02/01/202221984
  • Dermal tissue reconstructive material microbe-derived :
Gentherm Medical LLC12011 Mosteller Rd

Cincinnati
Ohio 45241

United States

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
04/28/202217724
  • Cardiopulmonary bypass system heating/cooling unit :
  • ,
  • Circulating-fluid whole-body heating/cooling system control unit :
Gentian ASBjornaasveien 5

Moss
Østfold 1596

Norway

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
03/29/202223882
  • Cystatin C IVD kit nephelometry/turbidimetry :
  • ,
  • Cystatin C IVD control :
  • ,
  • Cystatin C IVD calibrator :
  • ,
  • Calprotectin IVD calibrator :
  • ,
  • Calprotectin IVD control :
  • ,
  • Calprotectin IVD reagent :
Genzyme Corporation1125 Pleasant View Terrace

Ridgefield
NJ 07657

United States

Aventis Pharma Limited trading as SanofiUK Responsible Person410 Thames Valley Park Earley

Reading
RG6 1PT
UK Responsible Person
England United Kingdom
04/19/202218538
  • Synovial fluid supplementation medium :
George House Dental Laboratory13 Musbury Road

Axminster
Devon EX13 5JJ

United Kingdom







08/25/994942
  • Dental Appliances/Prostheses :
  • ,
  • Bonded dental bridge :
  • ,
  • Ceramic dental inlay :
  • ,
  • Bar dental precision attachment :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Crown surgical drill bit single-use :
  • ,
  • 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 :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental CAD/CAM system laboratory :
  • ,
  • Dental implant abutment analog laboratory :
  • ,
  • Dental implant abutment analog scanning :
  • ,
  • Dental implant analog :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental implant x-ray template :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Gold dental inlay :
  • ,
  • Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis :
  • ,
  • Orthodontic retainer :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Resin dental inlay :
  • ,
  • Root canal post custom-made :
  • ,
  • Temporary dental crown/bridge :
George King Bio-Medical Inc.11771 W. 112th Street

Overland Park
KS 66210

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
12/22/202121441
  • Lupus anticoagulant marker IVD control :
  • ,
  • Coagulation factor V IVD reagent :
  • ,
  • Coagulation factor VII IVD reagent :
  • ,
  • Coagulation factor VIII IVD reagent :
  • ,
  • Coagulation factor X IVD reagent :
  • ,
  • Coagulation factor XI IVD reagent :
  • ,
  • Coagulation factor XII IVD reagent :
  • ,
  • Coagulation factor XIII A subunit IVD control :
  • ,
  • Coagulation factor prekallikrein/kallikrein IVD control :
  • ,
  • Prothrombin time (PT) IVD control :
  • ,
  • Coagulation factor VIII-associated antigen IVD control :
  • ,
  • Multiple coagulation factor IVD control :
  • ,
  • Coagulation factor IX IVD reagent :
  • ,
  • Coagulation factor VIII inhibitor IVD control :
George Szekely Dental Laboratory LTD296 Brixton Hill

London
SW2 1HT

England United Kingdom
02086718580
t.dental@yahoo.com






04/10/20226673
  • Dental Appliances/Prostheses :
  • ,
  • Complete upper denture :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Complete lower denture :
  • ,
  • Partial denture :
  • ,
  • Denture reliner hard :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Resin dental inlay :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Bonded dental bridge :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Orthodontic retainer :
Georgina O'Callaghan35 Silverstreet Buckden
Cambridge
Cambridge
PE19 5TS

United Kingdom







03/28/20198465
  • Dental implantation drilling template custom-made :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental implant suprastructure permanent custom-made :
Geotek Medikal ve Saglik Hiz. Tic. San. Ltd. StiIvedik OSB Agac Metal Sitesi
1436. Sok. No:12 Ostim
Ankara
Yenimahalle 06370

Turkey

MCT Lifesciences LtdUK Responsible Person16 Hartdames
Shenley Brook End
Milton Keynes
Buckinghamshire MK5 7HP
UK Responsible Person
England United Kingdom
murat@mct-lifesciences.co.uk
04/15/202222595
  • Body aspiration needle single-use :
  • ,
  • Needle guide single-use :
  • ,
  • IVF oocyte aspiration needle single-use :
  • ,
  • Bone marrow biopsy needle single-use :
  • ,
  • Nephrostomy catheter introduction needle :
  • ,
  • Side-notch biopsy gun needle :
  • ,
  • Side-notch biopsy gun handpiece/needle :
  • ,
  • Biopsy gun handpiece :
Geratherm Medical AGFahrenheitstraße 1

Geratal
99331

Germany

Patient Guard LimitedUK Responsible PersonLancaster House Amy Johnson Way

Blackpool
Lancashire FY42RP
UK Responsible Person
United Kingdom
03/17/202223677
  • Capillary patient thermometer gallium-alloy :
  • ,
  • Automatic-inflation electronic sphygmomanometer portable arm/wrist :
  • ,
  • Intermittent electronic patient thermometer :
  • ,
  • Blood pressure cuff reusable :
  • ,
  • Infrared patient thermometer skin :
Geratherm Respiratory GmbHKasernenstraße 4

Bad Kissingen
97688

Germany

Love Medical LtdUK Responsible PersonUnit 1 Willan Enterprise Centre Fourth Avenue Trafford Park
MANCHESTER
MANCHESTER
Lancashire M17 1DB
UK Responsible Person
England United Kingdom
05/26/202114991
  • Patient monitoring system module multifunction :
  • ,
  • Pulmonary function analysis system adult :
  • ,
  • Medical equipment clinical data interfacing software :
  • ,
  • Cardiopulmonary stress exercise monitoring system :
  • ,
  • Environmental sensor :
  • ,
  • Pneumotachograph :
  • ,
  • Nose clip single-use :
  • ,
  • Diagnostic spirometer professional :
Gerhard Menzel GmbH a subsidiary of EprediaSaarbrückener Str. 248

Braunschweig
D-38116

Germany

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

Runcorn
Cheshire WA7 1TA
UK Responsible Person
United Kingdom
04/15/202113419
  • Microscope slide coverslip IVD :
  • ,
  • General specimen microscopy slide IVD single-use :
Gerium Medical Ltd.Gerium Medical
Hakishon Yavne
Rehovot
Central 8122017

Israel

Charter-Kontron LtdUK Responsible PersonAtlantic House 3 Michigan Drive
Tongwell Milton Keynes
Milton Keynes
Bucks MK15 8HQ
UK Responsible Person
England United Kingdom
info@charter-kontron.co.uk
04/13/202220544
  • Transcutaneous bilirubinometer :
German Medical Technology (Beijing) Co. Ltd.Building 68A No.16 Huan Ke Zhong Lu Jinqiao Science & Technology Industrial Base Zhongguancun Science Park Tongzhou Park Tongzhou District

Beijing
101102

China

KINGSMEAD SERVICE LIMITEDUK Responsible Person19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ
UK Responsible Person
England United Kingdom
office@kingsmead-service.com
01/31/202222397
  • Body aspiration needle single-use :
  • ,
  • Biopsy gun handpiece :
  • ,
  • End-cut biopsy gun needle :
  • ,
  • Bone marrow biopsy needle single-use :
  • ,
  • Bone marrow explant needle :
  • ,
  • Needle guide single-use :
Germitec3-5 allée de la Seine Bâtiment Paryseine

Ivry-sur-Seine
94200

France

International Associates LimitedUK Responsible Person38 Queen Street

Glasgow
G1 3DX
UK Responsible Person
Scotland United Kingdom
04/14/202215169
  • Ultraviolet disinfection light :
Gestenco International ABFridkullagatan 14

Gothenburg
SE-412 62

Sweden

Halliday Rorke Associates LLPUK Responsible PersonManor Cottages Abbots Leigh Road
Abbots Leigh
Bristol
North Somerset BS8 3QG
UK Responsible Person
United Kingdom
04/15/202221207
  • Dental etching solution :
  • ,
  • Orthodontic bracket adhesive :
  • ,
  • Orthodontic bracket metal :
  • ,
  • Orthodontic bracket plastic single-use :
  • ,
  • Orthodontic bracket ceramic :
  • ,
  • Self-ligating orthodontic bracket :
Getein Biotech Inc.No.9 Bofu Road Luhe District

Nanjing
211505

China

CMC Medical Devices LTDUK Responsible PersonOffice 32 19-21 Crawford Street

London
W1H 1PJ
UK Responsible Person
United Kingdom
02/09/202222849
  • Fluorescent immunoassay analyser IVD laboratory automated :
  • ,
  • Chemiluminescent immunoassay analyser IVD automated :
  • ,
  • D-dimer IVD kit chemiluminescent immunoassay :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit chemiluminescent immunoassay :
  • ,
  • C-peptide IVD kit chemiluminescent immunoassay :
  • ,
  • Insulin antibody IVD kit chemiluminescent immunoassay :
  • ,
  • Insulin IVD kit chemiluminescent immunoassay :
  • ,
  • C-reactive protein (CRP) IVD kit fluorescent immunoassay :
  • ,
  • Procalcitonin (PCT) IVD kit fluorescent immunoassay :
  • ,
  • Serum amyloid A IVD reagent :
  • ,
  • Interleukin-6 (IL-6) IVD reagent :
  • ,
  • Procalcitonin (PCT) IVD kit chemiluminescent immunoassay :
  • ,
  • Luteinizing hormone (LH) IVD kit chemiluminescent immunoassay :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT self-testing :
  • ,
  • SARS-CoV-2 antigen IVD kit rapid ICT clinical :
Gethin Jones T/A Moorside Dental PracticeMoorside Dental Practice 1 Forest Grove
Halifax
Halifax
West Yorkshire HX2 8AU

England United Kingdom
01422 229616
info@moorsidedental.com






02/08/202222787
  • Custom-made dental crown ceramic :
Getinge Disinfection AB.Ljungadalsgatan Växjö

Kronoberg
352 46,

Sweden

Getinge Ltd.UK Responsible Person14-15 Burford Way Boldon Business Park
Boldon Colliery Tyne and Wear
Boldon
NE35 9PZ
UK Responsible Person
England United Kingdom
06/15/202115312
  • Surgical utensil washer/disinfector :
  • ,
  • Endoscope washer/disinfector :
  • ,
  • Medical device disinfection agent :
  • ,
  • General-purpose drying cabinet :
  • ,
  • Endoscope drying/storage cabinet :
  • ,
  • Luminal device flushing tubing set reusable :
  • ,
  • Surgical utensil washer/disinfector :
  • ,
  • Sterilizer/disinfector rack :
GETINGE STERICOOL MEDIKAL ALETLER A.S. VE TCARET ANONM RKET BETEPE MALLES NERGZ SOK.
YENMAHALLE
ANKARA
NO: 7 / 2 / 71

Turkey

Getinge Ltd.UK Responsible Person14-15 Burford Way Boldon Business Park
Boldon Colliery Tyne and Wear
Boldon
NE35 9PZ
UK Responsible Person
England United Kingdom
11/08/202119585
  • Hydrogen peroxide gas sterilizer :
  • ,
  • Hydrogen peroxide device sterilant :
GeTrust (Xiamen) Medical Technology Co. Ltd.Building 1 No.289 Wengjiao Road Xinyang Industrial District Haicang

Xiamen
361022

China

SUNGO Certification Company LimitedUK Responsible Person3rd Floor 70 Gracechurch Street

London
EC3V 0HR
UK Responsible Person
England United Kingdom
01/04/202221090
  • Handgrip disability-assistive walker non-powered foldable :
Getsch & Hiller Medizintechnik GmbHSattlerstraße 20

Tuttlingen
78532

Germany

MEDAGENT INTERNATIONAL UK LIMITEDUK Responsible Person2 St Andrews Place

Lewes
East Sussex BN7 1UP
UK Responsible Person
England United Kingdom
04/15/202221420
  • Suturing unit single-use :
  • ,
  • Suturing unit single-use :
  • ,
  • Flexible endoscopic scissors reusable :
  • ,
  • Endoscope sheath reusable :
  • ,
  • Electrosurgical handpiece/electrode holder reusable :
  • ,
  • Rigid endoscopic biopsy forceps reusable :
  • ,
  • General surgery wound probe/packer :
  • ,
  • Suture cutter reusable :
  • ,
  • Nasal scissors :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Neurosurgical curette single-use :
  • ,
  • Surgical soft-tissue manipulation forceps scissors-like reusable :
  • ,
  • Meniscus knife :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Endoscopic electrosurgical electrode bipolar reusable :
GetSet Surgical SARoute de la Corniche 4

Epalinges
1066

Switzerland

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
07/06/202115715
  • Polymeric spinal interbody fusion cage :
  • ,
  • Internal spinal fixation procedure kit single-use :
  • ,
  • Bone-screw internal spinal fixation system sterile :
getUbetter LtdEngine Shed Station Approach
Temple Meads Aspull Wigan
Bristol
BS1 6QH

England United Kingdom
+447949148765
ianharrmill@hotmail.com






02/18/20209618
  • Alarm application software :
Geuder AGHertzstrasse 4

Heidelberg
69126

Germany

Daybreak Medical LtdUK Responsible PersonUnit 4 St Lawrence Business Centre Victoria Road

Feltham
TW13 7LT
UK Responsible Person
England United Kingdom
05/01/202214263
  • Ophthalmic surgical procedure kit non-medicated single-use :
  • ,
  • Ophthalmic surgical procedure kit non-medicated single-use :
  • ,
  • Ophthalmic surgical procedure kit medicated single-use :
GE.& AJ. GIBBS DENTAL LABORATORY.13 Stanhope Road Walthamstow

London
E17 9QT

United Kingdom







08/25/995368
  • Dental Appliances/Prostheses :
GF Health Products Inc.1 Graham Field Way

Atlanta
Georgia 30340

United States

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
11/04/202118539
  • Hospital stretcher manual :
  • ,
  • Hospital stretcher powered :
  • ,
  • General examination/treatment chair electric :
  • ,
  • Operating room stool :
  • ,
  • General examination/treatment chair manual :
GI Supply5069 Ritter Road Suite 104

Mechanicsburg
Pennsylvania 17055

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
07/30/202116424
  • Tissue marking ink :
  • ,
  • Tissue marking ink :
  • ,
  • Endoscopic bite block basic single-use :
  • ,
  • Submucosal lift solution :
Gibson's Dental Laboratory Limited77 The Boulevard

STOKE-ON-TRENT
Staffordshire ST6 6BD

United Kingdom







05/27/20091817
  • Complete lower denture :
  • ,
  • Orthodontic retainer :
  • ,
  • Custom-made mouthguard :
  • ,
  • Bite registration rim wax :
  • ,
  • Teeth whitening tray :
  • ,
  • Overdenture :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Preformed complete denture :
  • ,
  • Denture clasp metal custom-made :
  • ,
  • Dental impression tray single-use :
  • ,
  • Orthodontic clasp metal wire custom-made :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Partial denture :
Gill Eyecare Ltd145 High Street

Hornchurch
Essex RM11 3YD

United Kingdom







04/11/20227134
  • Low Vision Aids :
  • ,
  • Spectacle Lenses :
  • ,
  • Spectacle Frames :
Gimmi GmbHCarl-Zeiss-Straße 6

Tuttlingen
78532

Germany

MEDAGENT INTERNATIONAL UK LIMITEDUK Responsible Person2 St Andrews Place

Lewes
East Sussex BN7 1UP
UK Responsible Person
England United Kingdom
04/15/202217547
  • Endoscopic light source unit line-powered :
  • ,
  • Fibreoptic light cable :
  • ,
  • Endoscope video camera :
  • ,
  • Endoscope camera adaptor :
  • ,
  • Rigid optical hysteroscope :
  • ,
  • Rigid optical laparoscope :
  • ,
  • Suturing needle holder reusable :
  • ,
  • Uterine tenaculum :
  • ,
  • Orthopaedic joint/limb rongeur :
  • ,
  • Endoscopic electrosurgical handpiece/electrode monopolar reusable :
  • ,
  • Flexible endoscopic scissors reusable :
  • ,
  • Rigid endoscopic biopsy forceps reusable :
  • ,
  • Laparoscopic access cannula reusable :
  • ,
  • Laparoscopic dilation guide rod :
  • ,
  • Suturing unit reusable :
  • ,
  • General-purpose surgical scissors reusable :
  • ,
  • Electrosurgical handpiece reusable :
  • ,
  • Suture knot pusher reusable :
  • ,
  • Spring-loaded pneumoperitoneum needle reusable :
  • ,
  • Rigid endoscopic scissors reusable :
  • ,
  • Electrical-only medical device connection cable reusable :
  • ,
  • Endoscopic electrosurgical electrode monopolar reusable :
  • ,
  • Surgical soft-tissue manipulation forceps tweezers-like reusable :
  • ,
  • Surgical irrigation/aspiration cannula non-illuminating reusable :
  • ,
  • Rigid endoscope obturator :
  • ,
  • Rigid endoscope obturator :
  • ,
  • Endoscope sheath reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Hand-held surgical retractor reusable :
  • ,
  • Laparoscopic trocar blade reusable :
  • ,
  • Laparoscopic trocar blade reusable :
  • ,
  • Endoscopic electrosurgical handpiece/electrode bipolar reusable :
  • ,
  • Endoscope sheath reusable :
  • ,
  • Surgical irrigation/aspiration handpiece reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Open-surgery ligation clip applier :
  • ,
  • Arthroscopic probe :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • Surgical/emergency suction cannula non-illuminating reusable :
  • ,
  • General-purpose endoscopic needle reusable :
  • ,
  • Soft-tissue surgical hook reusable :
  • ,
  • Laparoscopic access cannula seal single-use :
  • ,
  • Luer/non-ISO80369-standardized linear connector reusable :
  • ,
  • Laparoscopic access cannula seal reusable :
  • ,
  • Endoscopic electrosurgical electrode bipolar reusable :
Giorgo Leventi43 Compton Close

London
NW1 3QS

England United Kingdom







10/27/202119627
  • Custom-made dental crown ceramic :
GISKIT MD B.V.Veerkade 5 F

Rotterdam
Zuid-Holland 3016 DE

Netherlands

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202218612
  • Ultrasound contrast medium transuterine administration :
GIVAS SRL35020 VILLATIRIA DI SAONARA Z.A.I VIALE VENETO 2

PADOVA
ITALY 35020

Italy

BARWORTH MEDICAL UK LIMITEDUK Responsible Person1ST FLOOR 130 HIGH STREET
MARLBOROUGH
MARLBOROUGH
WILTSHIRE SN8 1LZ
UK Responsible Person
England United Kingdom
11/30/202120246
  • Blood donor chair/couch :
Givas S.r.lViale Veneto 2 Z.A.

Villatora di Saonara
PD 35020

Italy

Caremed Alrick UK LtdUK Responsible PersonPort Stanley House 5 Falkland Close

Coventry
West Midlands CV4 8AU
UK Responsible Person
England United Kingdom
02/03/202221903
  • General examination/treatment chair manual :
  • ,
  • General examination/treatment chair electric :
GIVAS S.R.LVIALE VENETO 2 VILLATORA DI SAONARA

PADOVA
35020

Italy

Advena LtdUK Responsible PersonPure Offices Plato Close

Warwick
CV34 6WE
UK Responsible Person
England United Kingdom
03/22/202223710
  • Hospital stretcher manual :
  • ,
  • Neonatal bed :
Given Imaging Inc.15 Hampshire Street

Mansfield MA
02048

United States

Medtronic LimitedUK Responsible PersonBuilding 9 Croxley Park

Watford
Herts WD18 8WW
UK Responsible Person
England United Kingdom
11/06/202119659
  • Gastric pH ambulatory recorder :
  • ,
  • Gastric pH ambulatory recorder :
  • ,
  • Gastric pH ambulatory recorder :
  • ,
  • Gastrointestinal telemetric monitoring system :
  • ,
  • Gastrointestinal telemetric monitoring system :
  • ,
  • Gastrointestinal telemetric monitoring system :
  • ,
  • Gastrointestinal telemetric monitoring system :
  • ,
  • Manometric gastrointestinal motility analysis system :
  • ,
  • Manometric gastrointestinal motility analysis system :
  • ,
  • Video capsule endoscopy system application software :
  • ,
  • Video capsule endoscopy system capsule :
  • ,
  • Video capsule endoscopy system capsule :
  • ,
  • Video capsule endoscopy system application software :
  • ,
  • Video capsule endoscopy system application software :
GJM Implant Services Ltd7oaks Clinic 55 High Street
Sevenoaks
Sevenoaks
Kent TN13 1JF

England United Kingdom







01/11/202111488
  • Custom-made dental crown ceramic :
  • ,
  • Temporary dental crown/bridge :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental bridge ceramic :
GKC ManufacturingLevel 9 31 Queen Street

Melbourne
Victoria 3030

Australia

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
07/30/202116354
  • Neuromuscular motion disorder ambulatory recorder/analyser :
Glance Optical Pty Ltd104/430 Little Collins Street

Melbourne
Victoria 3000

Australia

Donawa Lifescience LtdUK Responsible PersonAviation Business Park Enterprise Close

Christchurch
BH23 6NX
UK Responsible Person
England United Kingdom
05/20/202114851
  • Visual field plotter :
Glasgow Dental Hospital and School378 Sauchiehall Street

Glasgow
G2 3JZ

Scotland United Kingdom







03/05/202112521
  • Temporary dental crown/bridge :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental bridge metal-ceramic :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Dental casting noble alloy :
  • ,
  • Dental bridge ceramic :
  • ,
  • Dental casting non-noble alloy :
  • ,
  • Dental veneer professional :
  • ,
  • Resin dental inlay :
  • ,
  • Ceramic dental inlay :
  • ,
  • Gold dental inlay :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental appliance fabrication material thermoplastic :
  • ,
  • Root canal post custom-made :
  • ,
  • Dental implantation depth/angle gauge single-use :
  • ,
  • Dental appliance fabrication material resin :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Partial denture :
  • ,
  • Dental acrylic resin :
  • ,
  • Denture reliner soft professional :
  • ,
  • Dental wrought alloy :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Overdenture :
  • ,
  • Bar dental precision attachment :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Resin artificial teeth :
  • ,
  • Denture clasp metal custom-made :
Glasgow Denture Studio Ltd3 Mount Stuart Street Shawlands

Glasgow
Lanarkshire G41 3YL

United Kingdom







04/10/20145167
  • Complete upper denture :
  • ,
  • Complete lower denture :
  • ,
  • Bite registration rim wax plate :
  • ,
  • Dental base plate :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Custom-made mouthguard :
  • ,
  • Overdenture :
  • ,
  • Partial denture :
  • ,
  • Denture clasp metal preformed :
  • ,
  • Polymer-based dental model material :
  • ,
  • Dental appliance fabrication material resin :
  • ,
  • Bite registration rim wax :
  • ,
  • Surgical implant template reusable :
  • ,
  • Surgical implant template single-use :
Glaukos Corporation229 Avenida Fabricante

San Clemente
California 92672

United States

UKCApartner4U LimitedUK Responsible Person7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR
UK Responsible Person
England United Kingdom
04/06/202224080
  • Glaucoma micro-stent :
Glaxo Operations UK Limited980 Great West Road

Brentford
Middlesex TW8 9GS

England United Kingdom







07/30/202216527
  • Cartridge-accepting autoinjector mechanical :
GlaxoSmithKline Trading Services Limited12 Riverwalk Citywest Business Campus

Dublin
Dublin 24

Ireland

GlaxoSmithKline UK LtdUK Responsible Person980 Great West Road

Brentford
Middlesex TW8 9GS
UK Responsible Person
England United Kingdom
12/22/202120797
  • Medicine chamber spacer reusable :
  • ,
  • Medicine chamber spacer reusable :
Gleamer5 Avenue de Général de Gaulle

Saint Mandé
94160

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
11/02/202118742
  • Radiology PACS software :
  • ,
  • Radiology PACS software :
Glenbio Ltd.10 Kilbegs Road

Antrim
Co. Antrim BT41 4NN

Northern Ireland United Kingdom







08/28/20157208
  • Benzodiazepine group IVD calibrator :
  • ,
  • Amphetamine-specific IVD kit enzyme immunoassay (EIA) :
  • ,
  • Amphetamine-specific IVD calibrator :
  • ,
  • Amphetamine-specific IVD control :
  • ,
  • Cocaine/cocaine metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cocaine/cocaine metabolite IVD calibrator :
  • ,
  • Cocaine/cocaine metabolite IVD control :
  • ,
  • Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA) :
  • ,
  • Opiate/opiate metabolite IVD calibrator :
  • ,
  • Opiate/opiate metabolite IVD control :
  • ,
  • Barbiturate IVD kit enzyme immunoassay (EIA) :
  • ,
  • Barbiturate IVD calibrator :
  • ,
  • Barbiturate IVD control :
  • ,
  • Cannabinoid IVD calibrator :
  • ,
  • Cannabinoid IVD kit enzyme immunoassay (EIA) :
  • ,
  • Cannabinoid IVD control :
  • ,
  • Benzodiazepine group IVD kit enzyme immunoassay (EIA) :
  • ,
  • Benzodiazepine group IVD control :
  • ,
  • Methadone IVD kit enzyme immunoassay (EIA) :
  • ,
  • Methadone IVD calibrator :
  • ,
  • Methadone IVD control :
  • ,
  • Phencyclidine (PCP) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Phencyclidine (PCP) IVD calibrator :
  • ,
  • Phencyclidine (PCP) IVD control :
  • ,
  • Amphetamine/methamphetamine group IVD kit enzyme immunoassay (EIA) :
  • ,
  • Amphetamine/methamphetamine group IVD calibrator :
  • ,
  • Amphetamine/methamphetamine group IVD control :
  • ,
  • Multiple therapeutic drugs/drugs of abuse IVD calibrator :
  • ,
  • Multiple therapeutic drugs/drugs of abuse IVD control :
  • ,
  • Alpha-1-antitrypsin (protease inhibitor) IVD reagent :
  • ,
  • Adenosine deaminase (ADA) IVD kit spectrophotometry :
  • ,
  • Acetaminophen IVD kit enzyme spectrophotometry :
  • ,
  • Total/prostatic acid phosphatase (TcP) IVD kit enzyme spectrophotometry :
  • ,
  • Alanine aminotransferase (ALT) IVD kit enzyme spectrophotometry :
  • ,
  • Albumin IVD kit spectrophotometry :
  • ,
  • Total alkaline phosphatase (ALP) IVD kit enzyme spectrophotometry :
  • ,
  • Total amylase IVD kit enzyme spectrophotometry :
  • ,
  • Angiotensin converting enzyme (ACE) IVD kit enzyme spectrophotometry :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD kit enzyme immunoassay (EIA) :
  • ,
  • Apolipoprotein A-I (Apo A1) IVD kit nephelometry/turbidimetry :
  • ,
  • Apolipoprotein B (Apo B) IVD kit nephelometry/turbidimetry :
  • ,
  • Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometry :
  • ,
  • Beta-hydroxybutyrate dehydrogenase IVD kit enzyme spectrophotometry :
  • ,
  • Carbon dioxide (CO2) IVD kit spectrophotometry :
  • ,
  • Conjugated (direct) bilirubin IVD kit enzyme spectrophotometry :
  • ,
  • Total bilirubin IVD kit spectrophotometry :
  • ,
  • Complement components C3/C3c IVD kit nephelometry/turbidimetry :
  • ,
  • Complement components C4/C4c IVD kit nephelometry/turbidimetry :
  • ,
  • Calcium (Ca2+) IVD kit spectrophotometry :
  • ,
  • Calprotectin IVD reagent :
  • ,
  • Ceruloplasmin IVD kit nephelometry/turbidimetry :
  • ,
  • Total cholesterol lipid IVD kit enzyme spectrophotometry :
  • ,
  • Cholinesterase dibucaine number (percentage inhibition) IVD kit enzyme spectrophotometry :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD kit enzyme spectrophotometry :
  • ,
  • Total creatine kinase (CK) IVD kit enzyme spectrophotometry :
  • ,
  • Copper IVD kit spectrophotometry :
  • ,
  • C-reactive protein (CRP) IVD kit nephelometry/turbidimetry :
  • ,
  • Creatinine IVD kit enzyme spectrophotometry :
  • ,
  • Cystatin C IVD kit nephelometry/turbidimetry :
  • ,
  • Ferritin IVD kit nephelometry/turbidimetry :
  • ,
  • Faecal occult blood IVD kit nephelometry/turbidimetry :
  • ,
  • Fructosamine IVD kit enzyme spectrophotometry :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD kit enzyme spectrophotometry :
  • ,
  • Gamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometry :
  • ,
  • Glucose IVD kit enzyme spectrophotometry :
  • ,
  • Haptoglobin IVD kit nephelometry/turbidimetry :
  • ,
  • Glycated haemoglobin (HbA1c) IVD kit enzyme spectrophotometry :
  • ,
  • Alpha-hydroxybutyrate dehydrogenase IVD kit enzyme spectrophotometry :
  • ,
  • High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometry :
  • ,
  • Homocysteine IVD kit enzyme spectrophotometry :
  • ,
  • Total immunoglobulin A (IgA total) IVD kit nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin E (IgE total) IVD kit nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin G (IgG total) IVD kit nephelometry/turbidimetry :
  • ,
  • Total immunoglobulin M (IgM total) IVD kit nephelometry/turbidimetry :
  • ,
  • Iron IVD kit spectrophotometry :
  • ,
  • Lactate IVD kit enzyme spectrophotometry :
  • ,
  • Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometry :
  • ,
  • Low density lipoprotein (LDL) cholesterol IVD kit enzyme spectrophotometry :
  • ,
  • Lipase IVD kit enzyme spectrophotometry :
  • ,
  • Lipoprotein A IVD kit nephelometry/turbidimetry :
  • ,
  • Magnesium (Mg2+) IVD kit spectrophotometry :
  • ,
  • Microalbumin IVD kit nephelometry/turbidimetry :
  • ,
  • Inorganic phosphate (PO43-) IVD kit spectrophotometry :
  • ,
  • Potassium (K+) IVD kit enzyme spectrophotometry :
  • ,
  • Prealbumin (transthyretin) IVD kit nephelometry/turbidimetry :
  • ,
  • Procalcitonin (PCT) IVD kit enzyme immunoassay (EIA) :
  • ,
  • Rheumatoid factor IVD kit agglutination :
  • ,
  • Salicylate IVD kit enzyme spectrophotometry :
  • ,
  • Sodium (Na+) IVD reagent :
  • ,
  • Total bile acid IVD kit enzyme spectrophotometry :
  • ,
  • Transferrin IVD kit nephelometry/turbidimetry :
  • ,
  • Triglyceride IVD kit enzyme spectrophotometry :
  • ,
  • Urea IVD kit enzyme spectrophotometry :
  • ,
  • Uric acid IVD kit enzyme spectrophotometry :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD kit enzyme immunoassay (EIA) :
  • ,
  • Total protein IVD kit spectrophotometry :
  • ,
  • Zinc IVD kit spectrophotometry :
  • ,
  • Angiotensin converting enzyme (ACE) IVD calibrator :
  • ,
  • Adenosine deaminase (ADA) IVD calibrator :
  • ,
  • Multiple apolipoprotein IVD calibrator :
  • ,
  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD calibrator :
  • ,
  • Beta-hydroxybutyrate IVD calibrator :
  • ,
  • Carbon dioxide (CO2) IVD calibrator :
  • ,
  • Calprotectin IVD calibrator :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD calibrator :
  • ,
  • Cystatin C IVD calibrator :
  • ,
  • Ferritin IVD calibrator :
  • ,
  • Faecal occult blood IVD calibrator :
  • ,
  • Fructosamine IVD calibrator :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD calibrator :
  • ,
  • Glycated haemoglobin (HbA1c) IVD calibrator :
  • ,
  • Homocysteine IVD calibrator :
  • ,
  • C-reactive protein (CRP) IVD calibrator :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD calibrator :
  • ,
  • Total immunoglobulin E (IgE total) IVD calibrator :
  • ,
  • Lipoprotein A IVD calibrator :
  • ,
  • Microalbumin IVD calibrator :
  • ,
  • Acetaminophen IVD calibrator :
  • ,
  • Potassium (K+) IVD calibrator :
  • ,
  • Procalcitonin (PCT) IVD calibrator :
  • ,
  • Rheumatoid factor IVD calibrator :
  • ,
  • Salicylate IVD calibrator :
  • ,
  • Sodium (Na+) IVD calibrator :
  • ,
  • Total bile acid IVD calibrator :
  • ,
  • Transferrin IVD calibrator :
  • ,
  • Multiple clinical chemistry protein IVD calibrator :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD calibrator :
  • ,
  • Adenosine deaminase (ADA) IVD control :
  • ,
  • Angiotensin converting enzyme (ACE) IVD control :
  • ,
  • Carbon dioxide (CO2) IVD control :
  • ,
  • Calprotectin IVD control :
  • ,
  • Creatine kinase myocardial isoenzyme (CKMB) IVD control :
  • ,
  • Cystatin C IVD control :
  • ,
  • Ferritin IVD control :
  • ,
  • Faecal occult blood IVD control :
  • ,
  • Fructosamine IVD control :
  • ,
  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD control :
  • ,
  • Glycated haemoglobin (HbA1c) IVD control :
  • ,
  • C-reactive protein (CRP) IVD control :
  • ,
  • Homocysteine IVD control :
  • ,
  • Total immunoglobulin E (IgE total) IVD control :
  • ,
  • Multiple-type clinical chemistry analyte profile IVD control :
  • ,
  • Microalbumin IVD control :
  • ,
  • Acetaminophen IVD control :
  • ,
  • Procalcitonin (PCT) IVD control :
  • ,
  • Multiple clinical chemistry protein IVD control :
  • ,
  • Multiple urine analyte IVD control :
  • ,
  • Multiple form 25-hydroxy Vitamin D IVD control :
  • ,
  • Chromogranin A IVD control :
Glisten Dental Technology Ltd6/F(West) Block C Zone A Fuhai Industrial Park
Fuyong Bao'an
Shenzhen
518103

China
02870832798
peter.king1@me.com
Portstewart Family Dental PracticeAuthorised Representative (Northern Ireland)6a Lever Road 6a Lever Road

Portstewart
County Londonderry BT55 7EF
Authorised Representative (Northern Ireland)
Northern Ireland United Kingdom
04/12/20228541
  • Dental bridge metal-ceramic :
  • ,
  • Dental bridge ceramic :
  • ,
  • Custom-made dental crown metal/ceramic :
  • ,
  • Custom-made dental crown ceramic :
  • ,
  • Custom-made dental crown metal :
  • ,
  • Custom-made dental crown polymer :
  • ,
  • Dental prosthesis/implant abutment screw :
  • ,
  • Gold dental inlay :
  • ,
  • Resin dental inlay :
  • ,
  • Dental appliance/prosthesis connector :
  • ,
  • Bar dental precision attachment :
  • ,
  • Dental occlusal splint custom-made :
  • ,
  • Dental bridge metal-polymer :
  • ,
  • Root canal post custom-made :
  • ,
  • Dental implant suprastructure permanent custom-made :
  • ,
  • Orthodontic retainer :
  • ,
  • Dental appliance fabrication material combination-material :
  • ,
  • Dental appliance fabrication material resin :
  • ,
  • Dental prosthesis bite verification device :
  • ,
  • Bite registration rim :
  • ,
  • Temporary dental crown/bridge resin :
  • ,
  • Dental bridge polymer :
  • ,
  • Dental veneer professional :
  • ,
  • Bonded dental bridge :
  • ,
  • Complete lower denture :
  • ,
  • Complete upper denture :
  • ,
  • Partial denture :
  • ,
  • Ceramic dental inlay :
Global-Thaixon Precision Industry Co. Ltd.83 Moo 1 Homsil
Bangpakong
Chacheongsao
24180

Thailand

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
03/12/202212616
  • Peripheral vascular guidewire manual :
Global Biomedica s.r.o.Ostravska 555/24

Cesky Tesin
73701

Czechia

Qserve Group UK Ltd. UK Responsible Person49 Greek Street

London
W1D 4EG
UK Responsible Person
England United Kingdom
04/15/202212049
  • Metallic spinal interbody fusion cage :
  • ,
  • Orthopaedic implant inserter/extractor reusable :
  • ,
  • Sterilization/disinfection container reusable :
  • ,
  • Surgical mallet :
  • ,
  • Orthopaedic chisel blade :
  • ,
  • Bone file/rasp manual reusable :
  • ,
  • Bone distraction forceps :
  • ,
  • Spinal implant trial :
  • ,
  • Neurosurgical curette single-use :
  • ,
  • Surgical instrument handle non-torque-limiting :
  • ,
  • Orthopaedic surgical distractor internal :
  • ,
  • Intraoperative bone pin/screw non-sterile :
Global Health and Safety87-89 Wigmore Street Mayfair

London
W1U 1DL

United Kingdom







07/01/202010228
  • Pressure bandage Hevea-latex reusable :
  • ,
  • Woven gauze roll non-sterile :
  • ,
  • Woven gauze pad non-sterile :
  • ,
  • Cotton wool ball non-sterile :
  • ,
  • Cotton wool roll non-sterile :
  • ,
  • Pressure bandage Hevea-latex single-use :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Skin treatment/dressing-supportive limb/finger bandage reusable :
  • ,
  • Non-adhesive device retention bandage :
  • ,
  • Compression bandaging kit :
  • ,
  • Pressure bandage non-latex single-use :
Global Instrumentation LLC8104 Cazenovia Road

Manlius
New York 13104

United States

Medes Ltd.UK Responsible Person5 Beaumont Gate Shenley Hil

Radlett
Herts WD77AR
UK Responsible Person
England United Kingdom
04/12/202113277
  • Electrocardiographic monitor :
  • ,
  • Electrocardiographic ambulatory recorder :
Global Manufacturing Group LtdUnit 7 1 Dock Road

London
London E16 1AH

England United Kingdom







06/03/202115144
  • Surgical/medical face mask single-use :
Global Manufacturing Technology Pty Ltd17 Bridge Street

Pymble
New South Wales 2073

Australia

Corin LimitedUK Responsible PersonThe Corinium Centre

Cirencester
Gloucestershire GL7 1YJ
UK Responsible Person
United Kingdom
07/27/202116305
  • Press-fit hip femur prosthesis one-piece :
  • ,
  • Uncoated hip femur prosthesis one-piece :
  • ,
  • Acetabular shell :
  • ,
  • Non-constrained polyethylene acetabular liner :
  • ,
  • Ceramic acetabular liner :
  • ,
  • Acetabulum prosthesis hole plug :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Ceramic femoral head prosthesis :
  • ,
  • Metallic femoral head prosthesis :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
  • ,
  • Orthopaedic surgical procedure kit non-medicated reusable :
Global Scientificunderwood Clack Lane
Osmotherley
NORTHALLERTON
DL6 3PN

England United Kingdom







10/06/202119136
  • Faecal specimen container IVD fixative :
Global Surgical Corporation3610 Tree Court Blvd

St Louis
Missouri 63122

United States

DP Medical Systems LimitedUK Responsible Person15a Oakcroft Road

Chessington
Surrey KT9 1RH
UK Responsible Person
England United Kingdom
12/22/202120828
  • Dental surgical microscope :
Globalcare Medical Technology Co. Ltd7th Building 39 Middle Industrial Main Road
European Industrial Zone Xiaolan
Zhongshan
Guangdong 528415

China

Donawa Lifescience LtdUK Responsible PersonAviation Business Park Enterprise Close

Christchurch
BH23 6NX
UK Responsible Person
England United Kingdom
08/20/202116928
  • Overhead infant phototherapy unit :
Globex Europe LimitedUnit C5 Atria Court Sterling Way

Papworth Everard
Cambridge CB23 3GY

United Kingdom







12/09/20165624
  • Stretchers/Chairs/Hospital Trolleys (Patient Transport) :
GLOBEX SAS3 RUE LOHIZUN-Z.A du Hillians

saint-pierre- d'irube
64990

France

M&N Optical LimitedUK Responsible PersonUnit 1 Millhayes Fore Street

Kentisbeare
Devon EX15 2AF
UK Responsible Person
England United Kingdom
02/01/202222564
  • Spectacle frame :
Globus Medical Inc.2560 General Armistead Avenue

Audubon
19403

United States

AJW Technology Consulting LtdUK Responsible Person4/4a Bloomsbury Square

London
WC1A 2RP
UK Responsible Person
England United Kingdom
04/13/202213409
  • Vertebral body prosthesis :
  • ,
  • Synthetic bone graft :
  • ,
  • General surgical procedure kit non-medicated single-use :
  • ,
  • Vertebral body prosthesis :
  • ,
  • Orthopaedic cement non-antimicrobial :
  • ,
  • Synthetic bone graft :
  • ,
  • Spinal fixation plate non-bioabsorbable :
  • ,
  • Balloon kyphoplasty kit :
  • ,
  • External orthopaedic fixation system single-use :
  • ,
  • External orthopaedic fixation system single-use sterile :
  • ,
  • Cervical total intervertebral disc prosthesis modular :
  • ,
  • Lumbar total intervertebral disc prosthesis :
  • ,
  • Orthopaedic bone screw non-bioabsorbable non-sterile :
  • ,
  • Lumbar interspinous decompression spacer sterile :
  • ,
  • Lumbar interspinous decompression spacer non-sterile :
  • ,
  • Metallic spinal interbody fusion cage :
  • ,
  • Arthrodesis nail sterile :
  • ,
  • Arthrodesis nail sterile :
  • ,
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable sterile :
  • ,
  • Metallic spinal interbody fusion cage :
  • ,
  • Spinal fixation plate non-bioabsorbable :
  • ,
  • Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile :
  • ,
  • Orthopaedic bone screw non-bioabsorbable sterile :
  • ,
  • Trans-facet-screw internal spinal fixation system sterile :
  • ,
  • Medullary canal orthopaedic reamer flexible :
  • ,
  • Fluted surgical drill bit reusable :
  • ,
  • Exploratory blunt needle single-use :
  • ,
  • Aspiration tray single-use :
  • ,
  • Robotic surgical navigation system :
  • ,
  • Robotic surgical navigation system :
  • ,
  • Surgical retraction system reusable :
  • ,
  • Exploratory blunt needle single-use :
  • ,
  • Balloon kyphoplasty kit :
  • ,
  • Orthopaedic surgical distractor internal :
  • ,
  • Bone access cannula :
  • ,
  • Nerve-locating system probe single-use :
  • ,
  • Cannulated surgical drill bit single-use sterile :
  • ,
  • Analytical non-scalp cutaneous lead :
  • ,
  • General surgical procedure kit non-medicated single-use :
  • ,
  • Medical ruler reusable :
  • ,
  • Orthopaedic prosthesis implantation instrument reusable :
Globus (Shetland) LtdT2 Trafford Point Twining Road
Trafford Park
Manchester
M17 1SH

England United Kingdom







03/18/202112750
  • Surgical gown reusable :
  • ,
  • Nitrile examination/treatment glove non-powdered non-antimicrobial :
  • ,
  • Surgical/medical face mask single-use :
  • ,
  • Transparent face mask single-use :
  • ,
  • Prescription spectacles :
  • ,
  • Surgical cap reusable :
Glooko ABNellickevägen 20

Göteborg
Västra Götalands Län 412 63

Sweden

Glooko LimitedUK Responsible Person24 Old Queen Street

London
SW1H 9HP
UK Responsible Person
England United Kingdom
11/23/202120195
  • Medical equipment clinical data interfacing software :
Glooko Inc.411 High Street

Palo Alto
California 94301

United States

Glooko LimitedUK Responsible Person24 Old Queen Street

London
SW1H 9HP
UK Responsible Person
England United Kingdom
12/22/202120667
  • Self-care monitoring/reporting software :
GLOS MEC Ltd65 Eastgate Street

Gloucester
Gloucestershire GL1 1PN

England United Kingdom







04/07/20224443
  • Prescribed Spectacles :