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Omega Black Thermoplastic 3/32 Smooth, 24 x 36 (2)

by North Coast Medical Inc.

Ref NC13300-4BModel 2690

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 Number0768627CSTACC-2690-T9 Basic UDI-DI 10768627006894UDI-DIDate4 Nov 2025RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Omega Black Thermoplastic
Model / Reference
2690, NC13300-4B
Primary DI / UDI-DI
10768627006894
Basic UDI-DI
0768627CSTACC-2690-T9
Direct Marketing DI
10768627006894
EMDN Code
M030504 Immobilisation systems, mouldable under cold and hot temperatures
Device Class
Class I

Manufacturer details

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

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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