Identity
- Trade Name
- iBEAM evo Stereotactic Adapter EUDAMEDiBEAM FDA UDI
- Generic Name
- Accelerator system table, non-powered FDA UDI
- Device Name
- iBEAM evo Couchtop, iBEAM one Couchtop EUDAMEDStereotactic Adapter FDA UDI
- Model / Reference
- P10105-425 EUDAMEDFDA UDI
- Description
- Stereotactic Adapter FDA UDI
Identifiers
- Catalog Number
- P10105-425 FDA UDI
- Primary DI / UDI-DI
- 04056719001346 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000003HY EUDAMED
- Direct Marketing DI
- 04056719001346 EUDAMED
- FDA Product Code
- IXQ FDA UDI
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Accelerator system table, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1980 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iBEAM evo Stereotactic Adapter 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 | 04056719BUDI0000000003HY | 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 (2)
- EUDAMED 95c4ee63-7b07-4155-b161-3e51293fe71e 61 fields · synced Jun 18, 2026
- FDA UDI ceb08518-e0bb-4edd-ae2a-cd998c187aef 34 fields · synced May 30, 2026