Skip to content

Wrist, Hand, Finger Splint

by Tiburon Medical Enterprises 174 variants

Ref 35304

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 Number065620411LV Basic UDI-DI 00656204000997UDI-DIDate27 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  • Withdrawn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
Wrist, Hand, Finger Splint
Model / Reference
35304
Primary DI / UDI-DI
00656204000997
Basic UDI-DI
065620411LV
EMDN Code
Y060613 Wrist-hand-fingers orthoses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000012145
Authorised representative
Code of Practice AB SE-AR-000003002

Other devices from Tiburon Medical Enterprises

See all devices from Tiburon Medical Enterprises →

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