Identity
- Trade Name
- Fraxion Mouthpiece X-Large P2 EUDAMEDFraxion FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- Fraxion EUDAMEDThe FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. FDA UDI
- Model / Reference
- P10106-329 EUDAMEDP10106-324 FDA UDI
- Description
- The FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. FDA UDI
Identifiers
- Catalog Number
- P10106-324 FDA UDI
- Primary DI / UDI-DI
- 04056719001797 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000002HW EUDAMED
- 510(k) Number
- K112210 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fraxion Mouthpiece X-Large P2 by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 04056719BUDI0000000002HW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
- EUDAMED SRN
- DE-MF-000023763
Sources (3)
- EUDAMED c270020a-be0a-4430-9a02-e7cc4ef5eb7b 61 fields · synced Jun 18, 2026
- FDA UDI be37afa8-3c8a-417e-8d60-1f7f7a726331 35 fields · synced May 30, 2026
- EUDAMED f4f43ddc-6493-4020-a1b2-520dd51e4811 61 fields · synced Jun 18, 2026