United Kingdom MHRA device registration 67650

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 67650
MHRA Reference Number: 67650
Date Registered: Nov 26, 2024
Last Updated: Feb 20, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd.
Address: Bldg. 2 and R101-R105/R201-240 of Bldg. 5, 568 Binkang Rd., Binjiang Dist.,
Hangzhou, , Zhejiang, China
Created Date: Feb 26, 2021

Authorized Representative

Name: NPZ technology Ltd
Relationship Type: UK Responsible Person
Address: Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach
Cambridge, Cambridgeshire, United Kingdom
Postcode: CB25 9QE

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About this record

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 67650. The device is manufactured by Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology Ltd.

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