United Kingdom MHRA device registration 103436

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Shenzhen Lvshiyuan Biotechnology Co.,Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 103436
MHRA Reference Number: 103436
Date Registered: Nov 26, 2024
Last Updated: Jun 14, 2024

Device classification

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

Manufacturer

Name: Shenzhen Lvshiyuan Biotechnology Co.,Ltd.
Address: D Building, No.2 Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New District, Shenzhen, 518120 China
Shenzhen, China
Created Date: Sep 9, 2021

Authorized Representative

Name: PureUKCA Ltd
Relationship Type: UK Responsible Person
Address: 59 St. Martin's Lane
London, Middlesex, England, United Kingdom
Postcode: WC2N 4JS

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About this record

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 103436. The device is manufactured by Shenzhen Lvshiyuan Biotechnology Co.,Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is PureUKCA Ltd.

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