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 - Xiamen Hopegen Medical Technology Co. Ltd.

Address:

Room 905 253 Duiying Nan Road Houxi Town Jimei District Xiamen

Fujian Province

361021

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 neutralizing antibody IVD kit rapid ICT clinical SARS-CoV-2 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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