United Kingdom MHRA device registration 104970

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

United Kingdom·In Vitro Diagnostic Device·Shanghai Bionaire Biotech Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 104970
MHRA Reference Number: 104970
Date Registered: Nov 26, 2024
Last Updated: Aug 8, 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: Shanghai Bionaire Biotech Co., Ltd.
Address: 4F Building 1,No.105,Sinan Road,Huangpu District
Shanghai, China
Created Date: Sep 18, 2021

Authorized Representative

Name: KINGSMEAD SERVICE LIMITED
Relationship Type: UK Responsible Person
Address: 19 MEZZANINE FLOOR 19-21 CRAWFORD STREET
London, England, United Kingdom
Postcode: W1H 1PJ

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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 104970. The device is manufactured by Shanghai Bionaire Biotech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is KINGSMEAD SERVICE LIMITED.

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