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Austofix Intramedullary Nailing System
EUDAMEDClass IIb (EU MDR)
Ref 391334Model S2 Supracondylar Nail | 13 x 340mm
Identity
- Trade Name
- Austofix Intramedullary Nailing System EUDAMED
- Model / Reference
- S2 Supracondylar Nail | 13 x 340mm EUDAMED391334 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09339430007862 EUDAMED
- Basic UDI-DI
- B-09339430007862 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-09339430007862 | 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 c1dc99ea-3569-494d-8d47-6b69dbc5da91 61 fields · synced Jun 19, 2026