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 - Oy Reagena Ltd

Address:

Takojantie 18

Toivala

70900

Finland

Authorised Representative/ UK Responsible Person
Name: Invitech Ltd
Address:

Unit 4 Molesworth Business Estate Molesworth

Huntingdon

Cambs PE28 0QG

United Kingdom

Code/Term Type

Biological stain IVD Biological stain IVD IVD General

Immunoassay reagent vehicle reader IVD Immunoassay reagent vehicle reader IVD Class A

C-X-C motif chemokine ligand 13 (CXCL13) IVD kit rapid ICT clinical C-X-C motif chemokine ligand 13 (CXCL13) IVD kit rapid ICT clinical IVD General

Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical IVD General

Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical IVD General

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA) Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA) IVD General

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical Borrelia burgdorferi 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
Biological stain IVD	Biological stain IVD	IVD General
Immunoassay reagent vehicle reader IVD	Immunoassay reagent vehicle reader IVD	Class A
C-X-C motif chemokine ligand 13 (CXCL13) IVD kit rapid ICT clinical	C-X-C motif chemokine ligand 13 (CXCL13) IVD kit rapid ICT clinical	IVD General
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical	Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD kit rapid ICT clinical	IVD General
Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical	Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD kit rapid ICT clinical	IVD General
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)	Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit enzyme immunoassay (EIA)	IVD General
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical	Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinical	IVD General