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TRIAMED, TRIAFIX ELBOW, Fixed elbow wrist hand orthosis

by Sc Triamed SRL 12 variants

Ref SRT214M2RModel SRT 200

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number594476005ORTMEMBRULSUPGM Basic UDI-DI 05944760053102UDI-DIDate31 Mar 2022RegisteredStatusActive

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  • Withdrawn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
Upper Limb Orthoses
Model / Reference
SRT 200, SRT214M2R
Primary DI / UDI-DI
05944760053102
Basic UDI-DI
594476005ORTMEMBRULSUPGM
EMDN Code
Y060619 Elbow-wrist-hand orthoses
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000002843

Other devices from Sc Triamed SRL

See all devices from Sc Triamed SRL →

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