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Austofix Intramedullary Nailing System
EUDAMEDClass IIb (EU MDR)
Ref 373040RModel F3 Femoral Nail 130 Deg | 10 x 400mm RIGHT
Identity
- Trade Name
- Austofix Intramedullary Nailing System EUDAMED
- Model / Reference
- F3 Femoral Nail 130 Deg | 10 x 400mm RIGHT EUDAMED373040R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09339430009125 EUDAMED
- Basic UDI-DI
- B-09339430009125 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
Austofix Intramedullary Nailing 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-09339430009125 | 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 af01dbcf-42bd-4f5a-bfae-e328d70fc1f9 61 fields · synced Jun 19, 2026