United Kingdom MHRA device registration 152958

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

United Kingdom·In Vitro Diagnostic Device·Shanghai BioGerm Medical Technology Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 152958
MHRA Reference Number: 152958
Date Registered: Nov 26, 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: Shanghai BioGerm Medical Technology Co., Ltd.
Address: Room 1302, 1303, 1304, 1305, 1306, 1307, 1309, Building 3, No. 1588 Huhang Road, Fengxian District,
Shanghai, China
Created Date: Jul 28, 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 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 152958. The device is manufactured by Shanghai BioGerm Medical Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath Limited.

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