Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Hangzhou Genesis Biodetection and Biocontrol Co. Ltd.

Address:

No.139 10th Street (East) Hangzhou Economic & Technological Development Zone

Zhejiang Province

310108

China

Authorised Representative/ UK Responsible Person
Name: SUNGO Certification Company Limited
Address:

3rd Floor 70 Gracechurch Street

London

EC3V 0HR

England United Kingdom

Code/Term Type

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical IVD General

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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