Identity
- Trade Name
- Blue Phantom³ EUDAMED
- Device Name
- myQA Blue Phantom³ EUDAMED
- Model / Reference
- BP03-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EIBAM1013880 EUDAMED
- Basic UDI-DI
- ++EIBABP37R EUDAMED
- Direct Marketing DI
- EIBAM1013880 EUDAMED
- EMDN Code
- Z119002 DOSIMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Blue Phantom³ by IBA Dosimetry GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EIBABP37R | Class IIb | Active |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (1)
- EUDAMED be1b89d8-2e79-46a8-a668-c49a7e942a58 61 fields · synced May 23, 2026