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 - DiaMex GmbH

Address:

Siemensstraße 38

Heidelberg

69123

Germany

Authorised Representative/ UK Responsible Person
Name: AB Scientific Ltd
Address:

124-128 City Road

London

Middlesex EC1V 2NX

England United Kingdom

Code/Term Type

Multiple infectious organism/newborn TORCH screen IVD control Multiple infectious organism/newborn TORCH screen IVD control IVD Annex II List B

Human T-cell lymphotrophic virus 2 (HTLV2) antibody IVD control Human T-cell lymphotrophic virus 2 (HTLV2) antibody IVD control IVD Annex II List A

HIV2 antibody IVD control HIV2 antibody IVD control IVD Annex II List A

HIV1 antigen IVD control HIV1 antigen IVD control IVD Annex II List A

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD control SARS-CoV-2 immunoglobulin M (IgM) antibody IVD control IVD General

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD control SARS-CoV-2 immunoglobulin G (IgG) antibody IVD control IVD General

Hepatitis B virus nucleic acid IVD control Hepatitis B virus nucleic acid IVD control IVD Annex II List A

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD control HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD control IVD Annex II List A

HIV1 nucleic acid IVD control HIV1 nucleic acid IVD control IVD Annex II List A

Hepatitis C virus nucleic acid IVD control Hepatitis C virus nucleic acid IVD control IVD Annex II List A

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD control Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD control IVD General

Parvovirus B19 immunoglobulin M (IgM) antibody IVD control Parvovirus B19 immunoglobulin M (IgM) antibody IVD control IVD General

Mumps virus immunoglobulin M (IgM) antibody IVD control Mumps virus immunoglobulin M (IgM) antibody IVD control IVD General

Measles virus immunoglobulin M (IgM) antibody IVD control Measles virus immunoglobulin M (IgM) antibody IVD control IVD General

Multiple exanthema-associated virus immunoglobulin G (IgG) antibody IVD control Multiple exanthema-associated virus immunoglobulin G (IgG) antibody IVD control IVD General

SARS-CoV-2 nucleic acid IVD control SARS-CoV-2 nucleic acid IVD control IVD General

Multiple blood-borne virus antigen/antibody IVD control Multiple blood-borne virus antigen/antibody IVD control IVD Annex II List A

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.