United Kingdom MHRA device registration 205434

Nucleic acid extraction/isolation kit IVD

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

Registration details

Device ID: 205434
MHRA Reference Number: 205434
Date Registered: Nov 26, 2024
Last Updated: Nov 21, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Nucleic acid extraction/isolation kit IVD
Type: Class A

Manufacturer

Name: Beijing OriginPoly Bio-Tec Co., Ltd.
Address: Room 401,No.6 Building & 3rd Floor, No.18 Building, Yard 50, Huatuo Road, Daxing Biomedical Industry Base, Zhongguancun Science and Technology Park, Daxing District
Beijing, China
Created Date: Nov 19, 2024

Authorized Representative

Name: SUNGO Certification Company Limited
Relationship Type: UK Responsible Person
Address: 3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR

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About this record

Nucleic acid extraction/isolation kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 205434. 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 SUNGO Certification Company Limited.

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