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Austofix Plate and Screw System

by Australian Orthopaedic Fixations Pty. Ltd. EUDAMED

Active European Union

Ref 4006-01-09182LModel L&C Distal Lateral Tibial Locking Plate | 9 Hole LEFT, 182mm

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09339430010879 Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
L&C Distal Lateral Tibial Locking Plate | 9 Hole LEFT, 182mm, 4006-01-09182L
Primary DI / UDI-DI
09339430010879
Basic UDI-DI
B-09339430010879
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

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Properties

Show 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