United Kingdom MHRA device registration 105552

Oral/upper respiratory tract specimen collection kit IVD, clinical

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Dewei Medical Equipment Co., Ltd·Registered Apr 11, 2024
Registration details
Device ID
105552
MHRA Reference Number
105552
Date Registered
Apr 11, 2024
Last Updated
Oct 4, 2023
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Oral/upper respiratory tract specimen collection kit IVD, clinical
Type
IVD General
Manufacturer
Address
5th Floor, No.4 Building, Shiyou Industrial Park, Jun'an, Shunde,
Foshan, Guangdong, China
Created Date
Apr 27, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
Office 32 19-21 Crawford Street
London, United Kingdom
Postcode: W1H 1PJ
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About this record

Oral/upper respiratory tract specimen collection kit IVD, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 105552. The device is manufactured by Dewei Medical Equipment Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is CMC Medical Devices LTD.

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