United Kingdom MHRA device registration 87425

Nucleic acid extraction/isolation kit IVD

United Kingdom·In Vitro Diagnostic Device·BioTeke Corporation (Wuxi) Co., Ltd·Registered Nov 26, 2024

Registration details

Device ID: 87425
MHRA Reference Number: 87425
Date Registered: Nov 26, 2024
Last Updated: Apr 26, 2024

Device classification

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

Manufacturer

Name: BioTeke Corporation (Wuxi) Co., Ltd
Address: 4th Floor, D5 & 2nd Floor, D3 & 1st and 2nd Floor, D16 No. 1719, Huishan Avenue, Wuxi
Jiangsu Province, China
Created Date: Mar 3, 2021

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 87425. The device is manufactured by BioTeke Corporation (Wuxi) Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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