Blue Phantom² M1013675
Blue Phantom² M1013675 is a Class II device made by IBA Dosimetry GmbH, registered in EUDAMED and listed in FDA GUDID since 9 Sep 2016 (UDI-DI EIBAM10136750), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | NumberEIBAM10136750 | Date9 Sep 2016 | StatusListed |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- EUDAMED Active
- FDA GUDID UDI-DI EIBAM10136750 listed 9 Sep 2016 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Blue Phantom²
- Generic name
- Accelerator system quality assurance device
- Model / reference
- M1013675
- Primary DI / UDI-DI
- EIBAM10136750
- FDA product code
- IYE
- GMDN term
- Accelerator system quality assurance device
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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