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 Huizhong Biotech Co. Ltd.

Address:

B1 Xia Gu 101 Fengyeyuan Industrial Factory Xingdong Community

Xin'an Sub-district Bao'an District

Shenzhen

518101

China

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

Enterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland

BT48 8SE

Northern Ireland United Kingdom

Code/Term Type

Spinal muscular atrophy (SMA) IVD kit nucleic acid technique (NAT) Spinal muscular atrophy (SMA) IVD kit nucleic acid technique (NAT) IVD General

Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT) Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT) IVD General

SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) 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
Spinal muscular atrophy (SMA) IVD kit nucleic acid technique (NAT)	Spinal muscular atrophy (SMA) IVD kit nucleic acid technique (NAT)	IVD General
Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT)	Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD kit nucleic acid technique (NAT)	IVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)	SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)	IVD General