Identity
- Trade Name
- iBEAM evo Couchtop EH EUDAMEDiBEAM FDA UDI
- Generic Name
- Accelerator system table, non-powered FDA UDI
- Device Name
- iBEAM evo Couchtop, iBEAM one Couchtop EUDAMEDiBEAM® evo Couchtop EH is intended to support the patient during radiation therapy or radiation therapy simulation. iBEAM® evo Couchtop EH is compatible to the Elekta Harmony PSS. FDA UDI
- Model / Reference
- P10105-184 EUDAMEDFDA UDI
- Description
- iBEAM® evo Couchtop EH is intended to support the patient during radiation therapy or radiation therapy simulation. iBEAM® evo Couchtop EH is compatible to the Elekta Harmony PSS. FDA UDI
Identifiers
- Catalog Number
- P10105-184 FDA UDI
- Primary DI / UDI-DI
- 04056719002251 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000003HY EUDAMED
- Direct Marketing DI
- 04056719002251 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Multi-modality therapeutic radiation phantom, test object
iBEAM evo Couchtop EH by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 cc71c9dd-8f48-46c6-a88e-337db2e49f58 61 fields · synced Aug 3, 2026
- FDA UDI 08746b9c-6ec7-4b2c-8464-5072ee827cd1 34 fields · synced May 30, 2026