United Kingdom MHRA device registration 68153

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

United Kingdom·In Vitro Diagnostic Device·Guangzhou KoFa Biotechnology Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 68153
MHRA Reference Number: 68153
Date Registered: Nov 26, 2024
Last Updated: Sep 5, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Guangzhou KoFa Biotechnology Co., Ltd.
Address: 5F/6F, Building C4, No.11 Kaiyuan Avenue Science City
Guangzhou City, Guangdong, China
Created Date: Mar 2, 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

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About this record

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 68153. The device is manufactured by Guangzhou KoFa Biotechnology 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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