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Apex Femoral Nail Retrograde Ø 8.5 x 480mm
EUDAMEDClass IIb (EU MDR)
Ref F05-850480
by OrthoXel DAC
Identity
- Trade Name
- Apex Femoral Nail Retrograde Ø 8.5 x 480mm EUDAMED
- Device Name
- Apex Femoral Nail Retrograde Ø 8.5 x 480mm EUDAMED
- Model / Reference
- F05-850480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391529588717 EUDAMED
- Basic UDI-DI
- B-05391529588717 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Apex Femoral Nail Retrograde Ø 8.5 x 480mm by OrthoXel DAC — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Apex Femoral Retrograde Nailing System
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-05391529588717 | Class IIb | Active |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (1)
- EUDAMED ad3b77e5-d3e0-489a-ac89-bd1e9652352b 61 fields · synced Oct 6, 2026