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 - Asan Pharmaceutical Co. Ltd.

Address:

122-26 Gieopdanji-ro Gongdo-eup

Anseong-si

Gyeonggi-do 17551

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

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

Oral/upper respiratory tract specimen collection kit IVD clinical Oral/upper respiratory tract specimen collection kit IVD clinical IVD General

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

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
Influenza A/B virus antigen IVD kit rapid ICT clinical	Influenza A/B virus antigen IVD kit rapid ICT clinical	IVD General
Oral/upper respiratory tract specimen collection kit IVD clinical	Oral/upper respiratory tract specimen collection kit IVD clinical	IVD General
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