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 - GenSure Biotech Inc.

Address:

B1-78 Rizhongtian Science and Technology Park No.585 Tianshan Street High-tech Zone

Shijiazhuang

Hebei 050000

China

Authorised Representative/ UK Responsible Person
Name: MedPath Limited
Address:

27 Old Gloucester Street

London

WC1N 3AX

England United Kingdom

Code/Term Type

Monkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical Monkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical 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 immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical	Monkeypox virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical	IVD General
Monkeypox virus antigen IVD kit rapid ICT clinical	Monkeypox virus antigen IVD kit rapid ICT clinical	IVD General