Identity
- Trade Name
- Blue Phantom Smartscan EUDAMEDSmartscan Waterphantom FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Blue Phantom SMARTSCAN EUDAMEDSmartscan Waterphantom including levelling pins FDA UDI
- Model / Reference
- SC02-000 EUDAMEDFDA UDI
- Description
- Smartscan Waterphantom including levelling pins FDA UDI
Identifiers
- Primary DI / UDI-DI
- EIBASC020000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBABPSMARTSCANFF EUDAMED
- Direct Marketing DI
- EIBASC020000 EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z119002 DOSIMETERS EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Blue Phantom Smartscan by IBA Dosimetry GmbH — Class IIb — 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 | ++EIBABPSMARTSCANFF | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (2)
- EUDAMED 88f79d0c-58e5-4643-9dfd-a0192377ea7a 61 fields · synced Jun 19, 2026
- FDA UDI 927ac760-6419-45da-b9ac-7f8ecd53f8e9 34 fields · synced May 30, 2026