United Kingdom MHRA device registration 155020

Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Tianjin Bioscience Diagnostic Technology Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 155020
MHRA Reference Number: 155020
Date Registered: Nov 26, 2024
Last Updated: Oct 8, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Monkeypox virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Tianjin Bioscience Diagnostic Technology Co., Ltd.
Address: Building 14, INT Medical Device Industrial Park, No. 16 Wujing Road, Dongli Economic and T&D Zone
Tianjin, China
Created Date: Jul 20, 2022

Authorized Representative

Name: SUNGO Certification Company Limited
Relationship Type: UK Responsible Person
Address: 3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR

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About this record

Monkeypox virus immunoglobulin M (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 155020. The device is manufactured by Tianjin Bioscience Diagnostic Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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