Identity
- Trade Name
- HexaPOD evo Extension long EUDAMEDiBEAM FDA UDI
- Generic Name
- Accelerator system table, non-powered FDA UDI
- Device Name
- iBEAM evo Couchtop, iBEAM one Couchtop EUDAMEDThe HexaPOD™ evo Extension long is designed to support the patients upper body and extends the end of the iBEAM® evo Couchtop integrated in to the HexaPOD™ evo Couchtop, thus allowing treatment of the abdominal area in very tall patients. This extension is dedicated for use with the HexaPOD™ evo RT System. FDA UDI
- Model / Reference
- P10105-426 EUDAMEDFDA UDI
- Description
- The HexaPOD™ evo Extension long is designed to support the patients upper body and extends the end of the iBEAM® evo Couchtop integrated in to the HexaPOD™ evo Couchtop, thus allowing treatment of the abdominal area in very tall patients. This extension is dedicated for use with the HexaPOD™ evo RT System. FDA UDI
Identifiers
- Catalog Number
- P10105-426 FDA UDI
- Primary DI / UDI-DI
- 04056719001926 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000003HY EUDAMED
- Direct Marketing DI
- 04056719001926 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
- Spain 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
HexaPOD evo Extension long 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 3b6990b7-fc3d-4158-a009-35c98fd9cb1d 61 fields · synced Jul 9, 2026
- FDA UDI cfbaf083-b04d-4cec-8640-213fbd0f10e4 34 fields · synced May 30, 2026