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Austofix Plate and Screw System

by Australian Orthopaedic Fixations Pty. Ltd. EUDAMED

Active European Union

Ref 2045-00-04063Model 3.5mm LC-L&C Locking Plate (Narrow) | 4 Hole, 59mm

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09339430019322 Basic UDI-DIDate20 May 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  • Withdrawn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

Model / Reference
3.5mm LC-L&C Locking Plate (Narrow) | 4 Hole, 59mm, 2045-00-04063
Primary DI / UDI-DI
09339430019322
Basic UDI-DI
B-09339430019322
EMDN Code
P09120503 Osteosynthesis screw-plate systems
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
AU-MF-000009151
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Australian Orthopaedic Fixations Pty. Ltd.

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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