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 - Sysmex Europe SE

Address:

Bornbarch 1

Norderstedt

22848

Germany

Authorised Representative/ UK Responsible Person
Name: OXFORD GENE TECHNOLOGY (OPERATIONS) LTD
Address:

Begbroke Science Park Begbroke Hill

Woodstock Road

Begbroke

Oxfordshire OX5 1PF

England United Kingdom

Code/Term Type

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD IVD General

Buffered sample diluent IVD Buffered sample diluent IVD IVD General

Buffered sample diluent IVD Buffered sample diluent IVD Class A

Buffered sample diluent IVD Buffered sample diluent IVD 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
Laboratory instrument/analyser application software IVD	Laboratory instrument/analyser application software IVD	IVD General
Buffered sample diluent IVD	Buffered sample diluent IVD	IVD General
Buffered sample diluent IVD	Buffered sample diluent IVD	Class A
Buffered sample diluent IVD	Buffered sample diluent IVD	Class A