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Sterile Cortical Fixation Devices

by Cousin Biotech 33 variants

Ref OAMGEFX15UModel COMETE

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-03760185573719 Basic UDI-DI 03760185573719UDI-DIDate1 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Sterile Cortical Fixation Devices
Model / Reference
COMETE, OAMGEFX15U
Primary DI / UDI-DI
03760185573719
Basic UDI-DI
B-03760185573719
EMDN Code
P099003 Orthopaedic prostheses fixing elements - not otherwise classified
Device Class
Class IIb
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001179

Other devices from Cousin Biotech

See all devices from Cousin Biotech →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No