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Omega Black Thermoplastic

by North Coast Medical Inc. 4 variants

Ref NC12796-1BModel 2690

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0768627CSTACC-2690-T9 Basic UDI-DI 00768627008792UDI-DIDate4 Nov 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  • Withdrawn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

Model / Reference
2690, NC12796-1B
Primary DI / UDI-DI
00768627008792
Basic UDI-DI
0768627CSTACC-2690-T9
Direct Marketing DI
00768627008792
EMDN Code
M030504 Immobilisation systems, mouldable under cold and hot temperatures
Device Class
Class I
EU market of registration
France

Manufacturer details

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

Other devices from North Coast Medical, Inc.

See all devices from North Coast Medical, Inc. →

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