United Kingdom MHRA device registration 155735

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Shenzhen Zijian Biotechnology Co., Ltd.·Registered Jul 31, 2024

Registration details

Device ID: 155735
MHRA Reference Number: 155735
Date Registered: Jul 31, 2024
Last Updated: Oct 4, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: Shenzhen Zijian Biotechnology Co., Ltd.
Address: 502, Building A, Qiaode Science Park, No.7, Guangming Hi-tech Park West, Tianliao Community, Yutang Street, Guangming District,
Shenzhen, Guangdong Province, China
Created Date: Sep 6, 2022

Authorized Representative

Name: CMC Medical Devices LTD
Relationship Type: UK Responsible Person
Address: Office 32 19-21 Crawford Street
London, United Kingdom
Postcode: W1H 1PJ

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About this record

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 155735. The device is manufactured by Shenzhen Zijian Biotechnology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is CMC Medical Devices LTD.

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