United Kingdom MHRA device registration 86022

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

United Kingdom·In Vitro Diagnostic Device·Zhongxiu Science and Technology Co., Ltd.·Registered Nov 19, 2024

Registration details

Device ID: 86022
MHRA Reference Number: 86022
Date Registered: Nov 19, 2024
Last Updated: Mar 26, 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: Zhongxiu Science and Technology Co., Ltd.
Address: Dingluan Industrial Zone, Changyuan City
Henan Province, China
Created Date: May 25, 2021

Authorized Representative

Name: SUNGO Certification Company Limited
Relationship Type: UK Responsible Person
Address: 3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR

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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 86022. The device is manufactured by Zhongxiu Science and Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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