United Kingdom MHRA device registration 156234

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Guangdong Wesail Biotech Co., Ltd.·Registered Nov 26, 2024
Registration details
Device ID
156234
MHRA Reference Number
156234
Date Registered
Nov 26, 2024
Last Updated
Oct 4, 2023
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Monkeypox virus antigen IVD, kit, rapid ICT, clinical
Type
IVD General
Manufacturer
Address
2F, Building 1, 5 Hualian Street, Songshan Lake Science and Technology Industrial Park, Songshan Lake,
Dongguan, Guangdong, China
Created Date
Sep 15, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
27 Old Gloucester Street
London, England, United Kingdom
Postcode: WC1N 3AX
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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 156234. The device is manufactured by Guangdong Wesail Biotech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath Limited.

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