Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Healgen Scientific

Address:

3818 Fuqua Street

Houston

Texas 77047

United States

Authorised Representative/ UK Responsible Person
Name: SENSUS Group Ltd
Address:

The Barn Tednambury Farm

Tednambury

Spellbrook

Hertfordshire CM23 4BD

England United Kingdom

Code/Term Type

Luteinizing hormone (LH) IVD kit rapid ICT clinical Luteinizing hormone (LH) IVD kit rapid ICT clinical IVD Devices for Self-Testing

Total prostate specific antigen (tPSA) IVD kit rapid ICT clinical Total prostate specific antigen (tPSA) IVD kit rapid ICT clinical IVD Annex II List B

Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid IVD Devices for Self-Testing

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Luteinizing hormone (LH) IVD kit rapid ICT clinical	Luteinizing hormone (LH) IVD kit rapid ICT clinical	IVD Devices for Self-Testing
Total prostate specific antigen (tPSA) IVD kit rapid ICT clinical	Total prostate specific antigen (tPSA) IVD kit rapid ICT clinical	IVD Annex II List B
Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid	Total human chorionic gonadotropin (HCG) IVD kit immunochromatographic test (ICT) rapid	IVD Devices for Self-Testing