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 - Amoena Medizin-Orthopädie-Technik GmbH

Address:

Amoena Medizin-Orthdadie-Technik GmbH Kapellen 36

Raubling

83064

Germany

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

1 Eagle Close

Chandlers Ford

Eastleigh

SO53 4NF

England United Kingdom

Code/Term Type

External breast prosthesis External breast prosthesis Class I

Scar management dressing reusable Scar management dressing reusable Class I

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
External breast prosthesis	External breast prosthesis	Class I
Scar management dressing reusable	Scar management dressing reusable	Class I