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Proprio Foot®

by Össur Iceland ehf. 398 variants

Ref PSX01427LModel BU00048

Proprio Foot® (PSX01427L) is a Class I device made by Össur Iceland ehf., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 5690967BU00048NM), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5690967BU00048NM Basic UDI-DI 05690967921750UDI-DIDate27 May 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
BU00048, PSX01427L
Primary DI / UDI-DI
05690967921750
Basic UDI-DI
5690967BU00048NM
EMDN code
Y062409 Transtibial prostheses (for amputation under knee)
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
IS-MF-000000173

Related devices

Category: Mechanical-resistance external ankle-foot prosthesis

Similar devices in this category

Other devices filed under EXTERNAL PROSTHESES AND ORTHOSES.

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Properties

Other properties (14, all answered No)