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 - OSARTIS GmbH

Address:

Auf der Beune 101

Münster

64839

Germany

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

Manual orthopaedic cement mixer single-use Manual orthopaedic cement mixer single-use Class I

Vertebral bone filler non-bioabsorbable Vertebral bone filler non-bioabsorbable Class IIb

Orthopaedic cement non-antimicrobial Orthopaedic cement non-antimicrobial Class IIb

Bone matrix implant synthetic non-antimicrobial Bone matrix implant synthetic non-antimicrobial Class III

Orthopaedic prosthesis implantation positioning instrument reusable Orthopaedic prosthesis implantation positioning instrument reusable Class I

Orthopaedic cement antimicrobial Orthopaedic cement antimicrobial Conformity Assessment Certificate Expired Class III

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
Manual orthopaedic cement mixer single-use	Manual orthopaedic cement mixer single-use	Class I
Vertebral bone filler non-bioabsorbable	Vertebral bone filler non-bioabsorbable	Class IIb
Orthopaedic cement non-antimicrobial	Orthopaedic cement non-antimicrobial	Class IIb
Bone matrix implant synthetic non-antimicrobial	Bone matrix implant synthetic non-antimicrobial	Class III
Orthopaedic prosthesis implantation positioning instrument reusable	Orthopaedic prosthesis implantation positioning instrument reusable	Class I
Orthopaedic cement antimicrobial	Orthopaedic cement antimicrobial Conformity Assessment Certificate Expired	Class III