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Episoft

by Orthosoft

Ref EP11XModel EPISOFT

Episoft (EP11X) is a Class I device made by Orthosoft, registered in EUDAMED on 18 Apr 2022 (Basic UDI-DI 3760270343401077455B), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3760270343401077455B Basic UDI-DI 03760270340035UDI-DIDate18 Apr 2022RegisteredStatusActive

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  • Withdrawn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
EPISOFT, EP11X
Primary DI / UDI-DI
03760270340035
Basic UDI-DI
3760270343401077455B
EMDN code
Y060615 Elbow orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000216

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Properties

Other properties (14, all answered No)