United Kingdom MHRA device registration 156592

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·GenSure Biotech Inc.·Registered Nov 26, 2024

Registration details

Device ID: 156592
MHRA Reference Number: 156592
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

Name: GenSure Biotech Inc.
Address: B1-78, Rizhongtian Science and Technology Park, No.585 Tianshan Street, High-tech Zone
Shijiazhuang , Hebei, China
Created Date: Sep 23, 2022

Authorized Representative

Name: MedPath Limited
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 156592. The device is manufactured by GenSure Biotech Inc. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath Limited.

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