United Kingdom MHRA device registration 167871

Hepatitis A virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Safecare Biotech (Hangzhou) Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 167871
MHRA Reference Number: 167871
Date Registered: Nov 26, 2024
Last Updated: Apr 16, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Hepatitis A virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Safecare Biotech (Hangzhou) Co., Ltd.
Address: Building 2/203, No.18 Haishu Rd. Cangqian Sub-district, Yuhang District,
Hangzhou, Zhejiang , China
Created Date: Nov 13, 2020

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

Hepatitis A virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 167871. The device is manufactured by Safecare Biotech (Hangzhou) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.

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