Manufacturer's By Device Colorectal cancer genotyping IVD kit nucleic acid technique (NAT)-Colorectal cancer genotyping IVD kit nucleic acid technique (NAT)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)7-C Industrial Area Govindpura
Bhopal
Bhopal
462023

India
Wellkang Ltd16 Castle St.

Dover
Kent CT16 1PW

England United Kingdom
05/17/202324647
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
BGI Europe A/SOle Maaløes Vej 3

Copenhagen
DK-2200

Denmark
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
09/07/202117963
Biovendor - Laboratorni medicina a.s.Karasek 1767/1

Brno
62100

Czechia
Oxford Biosystems Ltd184B Park Drive Milton Park
Abingdon
Abingdon
Oxfordshire OX14 4SE

United Kingdom
07/11/202225243
Entrogen Inc.Suite B 20950
Warner Center Ln Woodland Hills
Los Angeles
CA 91367

United States
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
05/18/202214718
ENVELOPE HEALTH BIOTECHNOLOGY CO. LTD.1203 No. 7 Building South Mingzhu apartment No. 21 Hongan 3 Street
Donghai community Yantian Street Yantian District
Shenzhen
518083

China
MedPath Limited27 Old Gloucester Street

London
WC1N 3AX

England United Kingdom
11/11/202119224
OÜ AntegenesRaatuse 21

Tartu
Tartumaa 50603

Estonia
Everything Genetic Ltd20-22 Wenlock Road

London
N1 7GU

England United Kingdom
10/21/202226645
QIAGEN GmbHQIAGEn GmbH
Qiagen Str. 1 Hilden
Mettmann
Düsseldorf 40724

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

England United Kingdom
03/19/202112724
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





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