SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 70385. The device is manufactured by Guangzhou Biotron Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

MHRA Device ID: 70385•Ref: 70385

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Mar 24, 2021

Last Updated

Oct 17, 2023

Manufacturer Information

Name

Guangzhou Biotron Technology Co., Ltd.

Address

Room 301& 401, Building C6, No. 11 Kaiyuan Road Huangpu District

Guangzhou, Guangdong, China

Created Date

Mar 24, 2021

Authorized Representative

Name

Wellkang Ltd

Relationship Type

Authorised Representative (Northern Ireland)

Address

Enterprise Hub, NW Business Complex 1 Beraghmore Road

Derry, Northern Ireland, Northern Ireland, United Kingdom

Postcode: BT48 8SE

DJ Fang

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SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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