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Orthosis Splints

by Performance Health Supply, LLC 6 variants

Ref 81293448Model Orthopedics

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08859140000000000000009L4 Basic UDI-DI 00885914037713UDI-DIDate20 Feb 2025RegisteredStatusActive

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  • Withdrawn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 Extremity
Model / Reference
Orthopedics, 81293448
Primary DI / UDI-DI
00885914037713
Basic UDI-DI
08859140000000000000009L4
EMDN Code
Y060613 Wrist-hand-fingers orthoses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000003318
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Performance Health Supply, LLC

See all devices from Performance Health Supply, LLC →

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