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 - Bloom Diagnostics AG

Address:

Susenbergstraße 185

Zürich

8044

Switzerland

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

Pure Offices Plato Close

Warwick

CV34 6WE

England United Kingdom

Code/Term Type

Thyroid stimulating hormone (TSH) IVD kit rapid ICT clinical Thyroid stimulating hormone (TSH) IVD kit rapid ICT clinical IVD General

Cystatin C IVD kit rapid ICT clinical Cystatin C IVD kit rapid ICT clinical IVD General

Ferritin IVD kit rapid ICT clinical Ferritin IVD kit rapid ICT clinical IVD General

Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Class A

C-reactive protein (CRP) IVD kit rapid ICT clinical C-reactive protein (CRP) 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
Thyroid stimulating hormone (TSH) IVD kit rapid ICT clinical	Thyroid stimulating hormone (TSH) IVD kit rapid ICT clinical	IVD General
Cystatin C IVD kit rapid ICT clinical	Cystatin C IVD kit rapid ICT clinical	IVD General
Ferritin IVD kit rapid ICT clinical	Ferritin IVD kit rapid ICT clinical	IVD General
Multi-modality clinical specimen analysis system IVD	Multi-modality clinical specimen analysis system IVD	Class A
C-reactive protein (CRP) IVD kit rapid ICT clinical	C-reactive protein (CRP) IVD kit rapid ICT clinical	IVD General