United Kingdom MHRA device registration 150662

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

United Kingdom·In Vitro Diagnostic Device·Healgen Scientific·Registered Nov 26, 2024

Registration details

Device ID: 150662
MHRA Reference Number: 150662
Date Registered: Nov 26, 2024
Last Updated: Sep 6, 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: Healgen Scientific
Address: 3818 Fuqua Street
Houston, Texas, United States
Created Date: Aug 20, 2021

Authorized Representative

Name: SENSUS Group Ltd
Relationship Type: UK Responsible Person
Address: The Barn Tednambury Farm Tednambury
Spellbrook, Hertfordshire, England, United Kingdom
Postcode: CM23 4BD

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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 150662. The device is manufactured by Healgen Scientific from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SENSUS Group Ltd.

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