United Kingdom MHRA device registration 89385

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Beijing Biosis Healing Biological Technology Co., Ltd·Registered Nov 26, 2024

Registration details

Device ID: 89385
MHRA Reference Number: 89385
Date Registered: Nov 26, 2024
Last Updated: Apr 29, 2024

Device classification

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

Manufacturer

Name: Beijing Biosis Healing Biological Technology Co., Ltd
Address: No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District
Beijing, China
Created Date: Jul 17, 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 neutralizing antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 89385. The device is manufactured by Beijing Biosis Healing Biological Technology Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology Ltd.

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