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 - EXBIO Praha a.s.

Address:

Nad Safinou II 341

Vestec

25250

Czechia

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

Sysmex House Garamonde Drive

Wymbush

Milton Keynes

Buckinghamshire MK8 8DF

England United Kingdom

Code/Term Type

Blood cell lysis reagent IVD Blood cell lysis reagent IVD IVD General

CD34 cell marker IVD antibody CD34 cell marker IVD antibody IVD General

Granulocyte IVD kit enzyme immunohistochemistry Granulocyte IVD kit enzyme immunohistochemistry IVD General

Multiple CD cell marker IVD antibody Multiple CD cell marker IVD antibody IVD General

Multiple CD cell marker IVD antibody Multiple CD cell marker IVD antibody Class A

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
Blood cell lysis reagent IVD	Blood cell lysis reagent IVD	IVD General
CD34 cell marker IVD antibody	CD34 cell marker IVD antibody	IVD General
Granulocyte IVD kit enzyme immunohistochemistry	Granulocyte IVD kit enzyme immunohistochemistry	IVD General
Multiple CD cell marker IVD antibody	Multiple CD cell marker IVD antibody	IVD General
Multiple CD cell marker IVD antibody	Multiple CD cell marker IVD antibody	Class A