United Kingdom MHRA device registration 100026

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical

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

Registration details

Device ID: 100026
MHRA Reference Number: 100026
Date Registered: Nov 26, 2024
Last Updated: Jul 31, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical
Type: IVD Annex II List B

Manufacturer

Name: Guangzhou Wondfo Biotech Co., Ltd.
Address: No.8 Lizhishan Road, Science City, Huangpu District
Guangzhou, China
Created Date: Mar 7, 2021

Authorized Representative

Name: Qarad UK Ltd.
Relationship Type: UK Responsible Person
Address: 8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY

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About this record

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 100026. The device is manufactured by Guangzhou Wondfo Biotech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK Ltd..

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