United Kingdom MHRA device registration 82135

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Hangzhou Sino-Europe Biomedical Science Park Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 82135
MHRA Reference Number: 82135
Date Registered: Nov 26, 2024
Last Updated: Mar 1, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Hangzhou Sino-Europe Biomedical Science Park Co., Ltd.
Address: No.9 Jiankang Road, Chengnan street, Tonglu County,
Hangzhou City, Zhejiang Province, China
Created Date: May 24, 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, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 82135. The device is manufactured by Hangzhou Sino-Europe Biomedical Science Park Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology Ltd.

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