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Orthosis Splints

by Performance Health Supply, LLC United States EUDAMED

Ref 81293307Model Orthopedics

EMDN Y060613

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Upper Extremity
Model / Reference
Orthopedics, 81293307
Primary DI / UDI-DI
00885914037645
Basic UDI-DI
08859140000000000000009L4
EMDN Code
Y060613 Wrist-hand-fingers orthoses
Device Class
Class I
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 & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED bab19c04-45b2-48b0-8d2c-1b481d13f3d1 61 fields · synced 22 Oct 2026