SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 80968. 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.

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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SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay

MHRA Device ID: 80968•Ref: 80968

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Feb 20, 2024

Manufacturer Information

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

DJ Fang

MedTech Regulatory Expert

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SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

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Address

DJ Fang

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