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Comfort Cool Ulnar Booster Splint R, L

by North Coast Medical Inc. EUDAMED

Active European Union

Ref NC68030-8Model 2890

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0768627ORTHO-2890-Q3 Basic UDI-DIDate30 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Comfort Cool Ulnar Booster
Model / Reference
2890, NC68030-8
Primary DI / UDI-DI
00768627001175
Basic UDI-DI
0768627ORTHO-2890-Q3
Direct Marketing DI
00768627001175
EMDN Code
Y060619 Elbow-wrist-hand orthoses
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000009087
Authorised representative
ICON (LR) Limited IE-AR-000006507

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Properties

Show 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