Manufacturer's By Device Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)-Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
3B BlackBio Biotech India Limited7-C Industrial Area Govindpura

Bhopal Madhya Pradesh
462023

India
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/06/202120343
Abbott GmbHMax-Planck-Ring 2

Wiesbaden
65205

Germany
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
01/24/202312352
Abbott Molecular Inc.1350 E. Touhy Ave

Des Plaines IL
Illinois 60018

United States
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
01/23/202313024
ACON Biotech (Hangzhou) Co LtdNo 210 Zhenzhong Road West Lake District

Hangzhou
310030

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202211766
Advanced Molecular Diagnostics LTD.Biocity Nottingham Pennyfoot Street

Nottingham
Nottinghamshire NG1 1GF

United Kingdom





02/12/20209591
Anatolia Tan ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AHasanpasa Mah. Beydagi Sk
No: 1-9 H
Istanbul
Sultanbeyli 34920

Turkey
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
04/28/202114050
Cepheid ABRöntgenvägen 5

Solna
171 54

Sweden
Cepheid UK LtdOakley Court Kingsmead Business Park
Frederick Place
High Wycombe
HP11 1JU

England United Kingdom
08/02/202112004
Diatech Pharmacogenetics S.r.lVia Ignazio Silone 1b

JESI
Ancona 60035

Italy
BS Partnership Ltd41 Dan-Y-Coed Road Cyncoed
CARDIFF
CARDIFF
WALES CF23 6NB

Wales United Kingdom
02/13/202327799
GeneFirst LimitedUnit 2 The Quadrant Abingdon Science Park
Abingdon
Oxfordshire
OX14 3YS

England United Kingdom





10/14/20166313
Hologic Inc.10210 Genetic Center Drive

San Diego
CA 92121

United States
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom
03/11/201669
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom





11/09/201768
Jiangsu Bioperfectus Technologies Co LtdNo 837 Yaocheng Avenue

Taizhou
Jiangsu 225300

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202212238
Prestige Diagnostics U.K. Ltd65 Fenaghy Road Galgorm

Ballymena
County Antrim BT42 1HW

Northern Ireland United Kingdom





07/21/20157207
PreTect ASUstadhagan 8

Klokkarstua
3490

Norway
MedEnvoy UK Limited85 Great Portland Street First Floor

London
W1W 7LT

England United Kingdom
12/07/202227230
QIAGEN Inc19300 Germantown Road Germantown

Germantown
MD 20874

United States
QIAGEN Manchester Ltd.QIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH

England United Kingdom
04/21/202113619
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715
Sansure Biotech Inc.No. 680 Lusong Road Yuelu District

Changsha
Hunan Province 410205

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/28/202117610
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
05/11/202114605
SHANGHAI ZJ BIO-TECH CO. LTD1st Floor Gate B Building #20 & 1st Floor Gate A Building #21 528 Ruiqing Road Zhangjiang High-Tech Industrial East District

Shanghai
201203

China
MedPath Limited27 Old Gloucester Street

London
WC1N 3AX

England United Kingdom
11/03/202226843
Shenzhen Uni-medica Technology Co. LtdRoom 202 Block 6th LiuXian Culture Park XiLi Town NanShan District

Shenzhen
Guangdong Province 518000

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/17/202225540