Identity
- Trade Name
- iGUIDE C-Frame EUDAMED
- Device Name
- HexaPOD evo RT System EUDAMED
- Model / Reference
- P10602-238 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056719002282 EUDAMED
- Basic UDI-DI
- 04056719BUDI0000000005J4 EUDAMED
- Direct Marketing DI
- 04056719002282 EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
iGUIDE C-Frame by 3C-Medical Intelligence GmbH — Class IIb — 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 | 04056719BUDI0000000005J4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
- EUDAMED SRN
- DE-MF-000023763
Sources (1)
- EUDAMED 910553f3-4e62-4ec4-87d7-80cd3616c9c5 61 fields · synced Jul 10, 2026