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 - Hoyotek Biomedical Co. Ltd.

Address:

Floor 4 Zone C Workshop No. 1 China Civil Aviation Science and Technology Industrialization Base No. 225 Jinger Road Tianjin Airport Economic Zone

Tianjin

300308

China

Authorised Representative/ UK Responsible Person
Name: QAdvis UK Ltd
Address:

55-66 Frederick Street

Edinburgh EH2 1LS

EH2 1LS

Scotland United Kingdom

Code/Term Type

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