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 - DxGen Corp.

Address:

Rm. 303-1 and Rm. 510 172 LS-ro

Gunpo-si

Gyeonggi-do 15807

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

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

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