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 Limited

Address:

3818 Fuqua Street

Houston

TX 7707

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

SARS-CoV-2 antigen IVD kit rapid ICT self-testing SARS-CoV-2 antigen IVD kit rapid ICT self-testing IVD Devices for Self-Testing

Barbiturate IVD kit rapid ICT clinical Barbiturate IVD kit rapid ICT clinical IVD General

Multiple drugs of abuse IVD kit rapid ICT clinical Multiple drugs of abuse IVD kit rapid ICT clinical IVD General

Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical IVD General

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
SARS-CoV-2 antigen IVD kit rapid ICT self-testing	SARS-CoV-2 antigen IVD kit rapid ICT self-testing	IVD Devices for Self-Testing
Barbiturate IVD kit rapid ICT clinical	Barbiturate IVD kit rapid ICT clinical	IVD General
Multiple drugs of abuse IVD kit rapid ICT clinical	Multiple drugs of abuse IVD kit rapid ICT clinical	IVD General
Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical	Respiratory syncytial virus (RSV) antigen IVD kit rapid ICT clinical	IVD General