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Fraxion - Product Combination System
EUDAMEDClass I (EU MDR)
Ref P10106-310, P10106-312, P10106-325, P10106-326, P10106-327, P10106-328, P10106-329
Identity
- Trade Name
- Fraxion - Product Combination System EUDAMED
- Device Name
- Fraxion - Product Combination System EUDAMED
- Model / Reference
- P10106-310, P10106-312, P10106-325, P10106-326, P10106-327, P10106-328, P10106-329 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056719002275 EUDAMED
- Basic UDI-DI
- 04056719BUDI0000000006J6 EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- For immobilization, positioning, and repositioning during Stereotactic Radiotherapy (SRT) in all parts of the brain and head in a Linear Accelerator environment. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Fraxion - Product Combination System by 3C-Medical Intelligence GmbH — 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 | 04056719BUDI0000000006J6 | Class I | Active |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
- EUDAMED SRN
- DE-PR-000023241
Sources (2)
- EUDAMED 68a93286-6113-4850-b926-911bb5e9f12d 61 fields · synced Jul 31, 2026
- EUDAMED 68a93286-6113-4850-b926-911bb5e9f12d-1 61 fields · synced Jun 9, 2026