United Kingdom MHRA device registration 196455

Human genomic analysis interpretive software IVD

United Kingdom·In Vitro Diagnostic Device·Genetron (Wuxi) Biotech Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 196455
MHRA Reference Number: 196455
Date Registered: Nov 26, 2024
Last Updated: Jul 9, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Human genomic analysis interpretive software IVD
Type: IVD General

Manufacturer

Name: Genetron (Wuxi) Biotech Co., Ltd.
Address: 5/F No. 8-6, Huide Road, Huishan Economic Development Zone
Wuxi, China
Created Date: Jul 4, 2024

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

Human genomic analysis interpretive software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 196455. The device is manufactured by Genetron (Wuxi) Biotech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath Limited.

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