Identity
- Trade Name
- EPIONE EUDAMED
- Device Name
- EPIONE EUDAMED
- Model / Reference
- 30-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760305400130 EUDAMED
- Basic UDI-DI
- 37603054001EPIONEUW EUDAMED
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Epione by Quantum Surgical SAS — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223758 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K211645 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 37603054001EPIONEUW | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantum Surgical SAS
- EUDAMED SRN
- FR-MF-000000600
Sources (2)
- EUDAMED 3f238339-aa26-499b-ac17-389dd74dafa9 85 fields · synced Jun 19, 2026
- FDA 510(k) K223758 1 fields · synced May 18, 2026