Identity
- Trade Name
- iBEAM evo CT Overlay Siemens MPT EUDAMEDiBEAM FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, non-powered FDA UDI
- Device Name
- iBEAM evo CT Overlay EUDAMEDiBEAM®evo CT Overlay Siemens MPT rests above the plane of the original CT Cradle. FDA UDI
- Model / Reference
- P10105-181 EUDAMEDFDA UDI
- Description
- iBEAM®evo CT Overlay Siemens MPT rests above the plane of the original CT Cradle. FDA UDI
Identifiers
- Catalog Number
- P10105-181 FDA UDI
- Primary DI / UDI-DI
- 04056719001179 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000004J2 EUDAMED
- Direct Marketing DI
- 04056719001179 EUDAMED
- FDA Product Code
- IXQ FDA UDI
- EMDN Code
- Z11010480 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Basic diagnostic x-ray system table, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1980 FDA UDI
- Market of Registration
- Germany 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 CT Overlay Siemens MPT 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 | 04056719BUDI0000000004J2 | 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 c7292cbb-a668-4c0b-8f14-ef5be16dcef9 61 fields · synced Jun 19, 2026
- FDA UDI 02b659b4-285c-4e83-b9d6-a790397a8006 34 fields · synced May 30, 2026