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Collar with Trachea Opening

by OPPO Medical Corp.

Ref 4096-BG-S-1, 4096-BG-M-1, 4096-BG-L-1

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 Number471986369CL105DM Basic UDI-DI Date25 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Cervical Spine Orthoses
Model / Reference
4096-BG-S-1, 4096-BG-M-1, 4096-BG-L-1
Primary DI / UDI-DI
04711769145609, 04711769145616, 04711769145623
Basic UDI-DI
471986369CL105DM
EMDN Code
Y060312 Cervical spine orthoses
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
TW-MF-000005201
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from OPPO Medical Corp.

See all devices from OPPO Medical Corp. →

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