Identity
- Device Name
- FFX ancillary EUDAMED
- Model / Reference
- 58.FXX.XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770019503447 EUDAMED
- Basic UDI-DI
- 377001950357001DE EUDAMED
- Direct Marketing DI
- 03770019503447 EUDAMED
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
FFX ancillary by Sc Medica — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 377001950357001DE | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Medica
- EUDAMED SRN
- FR-MF-000002722
Sources (1)
- EUDAMED e67ef4f0-ad49-4eaf-82c0-02d99be9c3fb 61 fields · synced Jun 19, 2026