Identity
- Trade Name
- SIORA EUDAMED
- Device Name
- PROXAFIX® PFNA Nail - Long 130 Deg. Left -Titanium - Dia. 11mm X Length 360mm EUDAMED
- Model / Reference
- Ti.064.11.360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907536037901 EUDAMED
- Basic UDI-DI
- B-08907536037901 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Siora by Siora Surgicals Pvt. 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-08907536037901 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siora Surgicals Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000036226
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED c2b2938b-78a6-487f-a258-b69d444df131 61 fields · synced Jun 18, 2026