United Kingdom MHRA device registration 155954

Methylated DNA IVD, reagent

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Beijing OriginPoly Bio-Tec Co., Ltd.·Registered Nov 26, 2024
Registration details
Device ID
155954
MHRA Reference Number
155954
Date Registered
Nov 26, 2024
Last Updated
Jan 24, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Methylated DNA IVD, reagent
Type
IVD General
Manufacturer
Address
3rd Floor, No. 18 Building, Yard 50, Huatuo Road, Daxing Biomedical Industry Base, Zhongguancun Science and Technology Park, Daxing District, Beijing.
Beijing, China
Created Date
Sep 2, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
59 St. Martin's Lane
London, Middlesex, England, United Kingdom
Postcode: WC2N 4JS
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About this record

Methylated DNA IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 155954. The device is manufactured by Beijing OriginPoly Bio-Tec Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is PureUKCA Ltd.

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