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 - Shenzhen Zijian Biotechnology Co. Ltd.

Address:

502 Building A Qiaode Science Park No.7 Guangming Hi-tech Park West Tianliao Community Yutang Street Guangming District

Shenzhen

Guangdong Province 518017

China

Authorised Representative/ UK Responsible Person
Name: CMC Medical Devices LTD
Address:

Office 32 19-21 Crawford Street

London

W1H 1PJ

United Kingdom

Code/Term Type

General specimen container IVD additive/medium General specimen container IVD additive/medium IVD General

Monkeypox virus antigen IVD kit rapid ICT clinical Monkeypox virus antigen IVD kit rapid ICT clinical IVD General

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

Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD IVD General

Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Class I

Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD 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
General specimen container IVD additive/medium	General specimen container IVD additive/medium	IVD General
Monkeypox virus antigen IVD kit rapid ICT clinical	Monkeypox virus antigen IVD kit rapid ICT clinical	IVD General
Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)	Monkeypox virus nucleic acid IVD kit nucleic acid technique (NAT)	IVD General
Nucleic acid extraction/isolation kit IVD	Nucleic acid extraction/isolation kit IVD	IVD General
Oral/upper respiratory tract specimen collection swab	Oral/upper respiratory tract specimen collection swab	Class I
Nucleic acid sample preparation instrument IVD	Nucleic acid sample preparation instrument IVD	IVD General