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 - BioDetect (Xiamen) Biotechnology Co. Ltd.

Address:

Building B9 and B5 Xiamen Biomedical Industrial Park 2066 Wengjiao West Road Xiamen

Fujian Province

301026

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

Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT) IVD General

Monkeypox virus antigen IVD kit rapid ICT clinical Monkeypox virus antigen 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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Code/Term		Type
Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)	Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)	IVD General
Monkeypox virus antigen IVD kit rapid ICT clinical	Monkeypox virus antigen IVD kit rapid ICT clinical	IVD General