United Kingdom MHRA device registration 107687

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

United Kingdom·In Vitro Diagnostic Device·ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.·Registered Nov 26, 2024

Registration details

Device ID: 107687
MHRA Reference Number: 107687
Date Registered: Nov 26, 2024
Last Updated: Aug 14, 2024

Device classification

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

Manufacturer

Name: ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.
Address: 1203, No. 7 Building, South Mingzhu apartment, No. 21 Hongan 3 Street, Donghai community, Yantian Street, Yantian District,
Shenzhen, China
Created Date: Oct 11, 2021

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 107687. The device is manufactured by ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedPath Limited.

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