Identity
- Trade Name
- Dosimax plus duo EUDAMEDDosimeter Dosimax plus duo FDA UDI
- Generic Name
- Diagnostic x-ray system quality assurance device FDA UDI
- Device Name
- Dual channel dosimeter especially for quality checks at radiographic and fluoroscopic X-ray units, combined with sandwich detector DE2DX for simultaneous measurement of entrance- and exit dose. FDA UDI
- Model / Reference
- Dosimax EUDAMEDVD0201460 EUDAMEDFDA UDI
- Description
- Dual channel dosimeter especially for quality checks at radiographic and fluoroscopic X-ray units, combined with sandwich detector DE2DX for simultaneous measurement of entrance- and exit dose. FDA UDI
Identifiers
- Catalog Number
- VD0201460 FDA UDI
- Primary DI / UDI-DI
- EIBAVD02014600 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBADOSIMAX5G EUDAMED
- Direct Marketing DI
- EIBAVD02014600 EUDAMED
- FDA Product Code
- LHO FDA UDI
- EMDN Code
- Z119002 DOSIMETERS EUDAMED
- GMDN Term
- Diagnostic x-ray system quality assurance device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1940 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dosimax plus duo by IBA Dosimetry GmbH — Class I — 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 | ++EIBADOSIMAX5G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (2)
- EUDAMED 4d022fd0-3fd2-45ac-899e-d68dbafa6753 61 fields · synced Oct 6, 2026
- FDA UDI 371535db-af6a-44a5-8bc9-ac447b610604 35 fields · synced May 30, 2026