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Austofix Intramedullary Nailing System
EUDAMEDClass IIb (EU MDR)
Ref 391124Model S2 Supracondylar Nail | 11 x 240mm
Identity
- Trade Name
- Austofix Intramedullary Nailing System EUDAMED
- Model / Reference
- S2 Supracondylar Nail | 11 x 240mm EUDAMED391124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09339430007633 EUDAMED
- Basic UDI-DI
- B-09339430007633 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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
Category: Arthrodesis intramedullary nail, non-distracting
Austofix Intramedullary Nailing System by Australian Orthopaedic Fixations Pty. Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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-09339430007633 | 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 aff4dd03-fc5d-4248-be87-4f1c0047b9b4 61 fields · synced Jun 18, 2026