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 - Planmed Oy

Address:

Sorvajaankatu 7

Helsinki

00880

Finland

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

3 Oak Court Pilgrims Walk

Prologis Park

Coventry

CV6 4QH

England United Kingdom

Code/Term Type

Stationary mammographic x-ray system digital Stationary mammographic x-ray system digital Class IIb

Limited-view-field CT system Limited-view-field CT system Class IIb

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Class IIb

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
Stationary mammographic x-ray system digital	Stationary mammographic x-ray system digital	Class IIb
Limited-view-field CT system	Limited-view-field CT system	Class IIb
Mammographic stereotactic biopsy system	Mammographic stereotactic biopsy system	Class IIb