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 - Fillauer Europe AB

Address:

Kung Hans Väg 2

Sollentuna

19268

Sweden

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

External lower-limb prosthesis suspensory component non-powered External lower-limb prosthesis suspensory component non-powered Class I

Passive elbow prosthesis locking Passive elbow prosthesis locking Class I

Passive hand prosthesis Passive hand prosthesis Class I

Ankle/foot orthosis Ankle/foot orthosis Class I

External limb prosthesis finishing component non-customized External limb prosthesis finishing component non-customized 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 lower-limb prosthesis suspensory component non-powered	External lower-limb prosthesis suspensory component non-powered	Class I
Passive elbow prosthesis locking	Passive elbow prosthesis locking	Class I
Passive hand prosthesis	Passive hand prosthesis	Class I
Ankle/foot orthosis	Ankle/foot orthosis	Class I
External limb prosthesis finishing component non-customized	External limb prosthesis finishing component non-customized	Class I