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Fraxion Linac Table Top Adapter iBe (0DoF)
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10106-132
Identity
- Trade Name
- Fraxion Linac Table Top Adapter iBe (0DoF) EUDAMEDFraxion FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- Fraxion EUDAMEDFRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. FDA UDI
- Model / Reference
- P10106-132 EUDAMEDFDA UDI
- Description
- FRAXION™ is secured to the treatment table top by various tabletop adapter depending on treatment table. FDA UDI
Identifiers
- Catalog Number
- P10106-132 FDA UDI
- Primary DI / UDI-DI
- 04056719001506 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000002HW EUDAMED
- Direct Marketing DI
- 04056719001506 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
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fraxion Linac Table Top Adapter iBe (0DoF) by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 8571e38d-a32e-4bb7-a378-e1c1a50f58e7 61 fields · synced Jun 19, 2026
- FDA UDI 041da54a-cb3e-4e64-b319-4daababd5d0d 35 fields · synced May 29, 2026
- EUDAMED f650b069-b42e-4e42-88f5-b3a42f6b5d7f 61 fields · synced Jun 19, 2026