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

Back to MHRA

Manufacturer's Devices - Sugentech Inc.

Address:

721-26 Jeongjungyeonje-ro Osong-eup Heungdeok-gu

Cheongju-si

Chungcheongbuk-do 28161

South Korea

Authorised Representative/ UK Responsible Person
Name: MT Promedt Consulting Ltd
Address:

Beaver House 23-38 Hythe Bridge Street

Oxford

OX1 2EP

England United Kingdom

Code/Term Type

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapid IVD Devices for Self-Testing

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

Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD IVD Devices for Self-Testing

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 Devices for Self-Testing

Influenza A/B virus antigen IVD kit rapid ICT clinical Influenza A/B virus antigen IVD kit rapid ICT clinical IVD General

Influenza A/B virus antigen IVD kit rapid ICT clinical Influenza A/B virus 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

© 2011 Crown Copyright. To contact us about this website, use our feedback form.

Code/Term		Type
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapid	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD kit immunochromatographic test (ICT) rapid	IVD Devices for Self-Testing
Luteinizing hormone (LH) IVD kit rapid ICT clinical	Luteinizing hormone (LH) IVD kit rapid ICT clinical	IVD Devices for Self-Testing
Photometric/spectroscopic immunoassay analyser IVD	Photometric/spectroscopic immunoassay analyser IVD	IVD Devices for Self-Testing
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 Devices for Self-Testing
Influenza A/B virus antigen IVD kit rapid ICT clinical	Influenza A/B virus antigen IVD kit rapid ICT clinical	IVD General
Influenza A/B virus antigen IVD kit rapid ICT clinical	Influenza A/B virus antigen IVD kit rapid ICT clinical	IVD General