United Kingdom MHRA device registration 155599

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

United Kingdom·In Vitro Diagnostic Device·Beijing OriginPoly Bio-Tec Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 155599
MHRA Reference Number: 155599
Date Registered: Nov 26, 2024
Last Updated: Jan 24, 2024

Device classification

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

Manufacturer

Name: Beijing OriginPoly Bio-Tec Co., Ltd.
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

Name: PureUKCA Ltd
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, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 155599. 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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