United Kingdom MHRA device registration 160506

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Wuhan Life Origin Biotech Joint Stock Co., Ltd.·Registered Nov 19, 2024

Registration details

Device ID: 160506
MHRA Reference Number: 160506
Date Registered: Nov 19, 2024
Last Updated: Oct 8, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Monkeypox virus antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Wuhan Life Origin Biotech Joint Stock Co., Ltd.
Address: Floor 1st, 2nd and 3rd, Wuhan Hi-Tech Medical Device Park B11, No. 818 Gaoxin Avenue Donghu Hi-Tech Development Zone, Wuhan
Hubei Province, China
Created Date: Nov 14, 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 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 160506. The device is manufactured by Wuhan Life Origin Biotech Joint Stock 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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