Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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

MHRA Device ID: 150662•Ref: 150662

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD Annex II List B

Date Registered

Nov 26, 2024

Last Updated

Sep 6, 2024

Manufacturer Information

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

DJ Fang

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Other Products from Same Authorized Representative (10)

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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