United Kingdom MHRA device registration 171411

Methylated DNA IVD, kit, nucleic acid technique (NAT)

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

Registration details

Device ID: 171411
MHRA Reference Number: 171411
Date Registered: Nov 26, 2024
Last Updated: Feb 6, 2024

Device classification

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

Manufacturer

Name: Genetron Health (Beijing) Co., Ltd.
Address: 1-5/F 101 (Room 301 & 303 & 304, 3F) of Building 10, 1-5/F 101 (Room 201, 2F) of Building 11, Zone 1 No. 8 Life Science Parkway, Changping District
Beijing, China
Created Date: May 2, 2023

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

Methylated DNA 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 171411. The device is manufactured by Genetron Health (Beijing) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath Limited.

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