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Omni Stable AF

by Extremity Medical, LLC EUDAMED

Active European Union

Ref 148-35451-S

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00842078141571 Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
4.5mm Screw Washer -Sterile
Model / Reference
148-35451-S
Primary DI / UDI-DI
00842078141571
Basic UDI-DI
B-00842078141571
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018334
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

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