United Kingdom MHRA device registration 87424

Nucleic acid sample preparation instrument IVD

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·BioTeke Corporation (Wuxi) Co., Ltd·Registered Nov 26, 2024
Registration details
Device ID
87424
MHRA Reference Number
87424
Date Registered
Nov 26, 2024
Last Updated
Apr 26, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Nucleic acid sample preparation instrument IVD
Type
IVD General
Manufacturer
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
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 sample preparation instrument IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 87424. 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.

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