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Novacast

by Novankle

Ref ORT01002, ORT01003, ORT01001Model Novacast

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0069905100058449Q Basic UDI-DI Date3 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Attelle stabilisatrice cheville & médio-pied polyvalente permettant de traiter toutes les entorses
Model / Reference
Novacast, ORT01002, ORT01003, ORT01001
Primary DI / UDI-DI
37700343150182, 37700343150328, 37700343150250
Basic UDI-DI
0069905100058449Q
EMDN Code
Y06120601 Passive ankle-foot orthoses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000038041

Related devices

Category: Ankle/foot orthosis

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No