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

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Manufacturer's Devices - CIGA Healthcare Ltd

Address:

27 Kildowney Road

Kilcran House

Ballymena

BT44 9EY

Northern Ireland United Kingdom

Authorised Representative/ UK Responsible Person
Name: Not Available

Address:

Code/Term Type

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical IVD General

Multiple urine analyte IVD kit rapid colorimetric clinical Multiple urine analyte IVD kit rapid colorimetric clinical IVD General

Multiple urine analyte IVD kit rapid colorimetric self-testing Multiple urine analyte IVD kit rapid colorimetric self-testing IVD Devices for Self-Testing

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

Luteinizing hormone (LH) IVD kit rapid ICT self-testing Luteinizing hormone (LH) IVD kit rapid ICT self-testing 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
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical	SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical	IVD General
Multiple urine analyte IVD kit rapid colorimetric clinical	Multiple urine analyte IVD kit rapid colorimetric clinical	IVD General
Multiple urine analyte IVD kit rapid colorimetric self-testing	Multiple urine analyte IVD kit rapid colorimetric self-testing	IVD Devices for Self-Testing
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
Luteinizing hormone (LH) IVD kit rapid ICT self-testing	Luteinizing hormone (LH) IVD kit rapid ICT self-testing	IVD Devices for Self-Testing