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Austofix Plate and Screw System
EUDAMEDClass IIb (EU MDR)
Ref 4005-01-10194RModel 3.5mm L&C Distal Medial Tibial Locking Plate | 10 Hole RIGHT, 198mm
Identity
- Trade Name
- Austofix Plate and Screw System EUDAMED
- Model / Reference
- 3.5mm L&C Distal Medial Tibial Locking Plate | 10 Hole RIGHT, 198mm EUDAMED4005-01-10194R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09339430010817 EUDAMED
- Basic UDI-DI
- B-09339430010817 EUDAMED
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Austofix Plate and Screw System by Australian Orthopaedic Fixations Pty. Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09339430010817 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Australian Orthopaedic Fixations Pty. Ltd.
- EUDAMED SRN
- AU-MF-000009151
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b8c750aa-c8df-4ecc-b4a9-0b893ed8f5fd 61 fields · synced Aug 3, 2026