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 - oneFIT medical

Address:

18 rue Alain SAVARY

Besançon

25000

France

Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge

CB24 9BZ

England United Kingdom

Code/Term Type

Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Class I

Multidisciplinary medical image management software Multidisciplinary medical image management software Class I

Joint prosthesis implantation kit single-use Joint prosthesis implantation kit single-use Class IIa

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
Orthopaedic/craniofacial implantation planning software	Orthopaedic/craniofacial implantation planning software	Class I
Multidisciplinary medical image management software	Multidisciplinary medical image management software	Class I
Joint prosthesis implantation kit single-use	Joint prosthesis implantation kit single-use	Class IIa