Identity
- Trade Name
- KermaX-plus 120-131 RS-ZK EUDAMEDKermaX-plus FDA UDI
- Generic Name
- Diagnostic x-ray system quality assurance device FDA UDI
- Device Name
- KermaX Plus EUDAMEDKermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time. FDA UDI
- Model / Reference
- 120-131 RS-ZK EUDAMED1 FDA UDI
- Description
- KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time. FDA UDI
Identifiers
- Catalog Number
- 120-131 RS-ZK FDA UDI
- Primary DI / UDI-DI
- EIBA120131RSZK0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EIBAKERMAXPLUSPQ EUDAMED
- Direct Marketing DI
- EIBA120131RSZK0 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 IIb EUDAMEDClass I FDA 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
No
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
KermaX-plus 120-131 RS-ZK 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 | ++EIBAKERMAXPLUSPQ | 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 e0670459-4788-43ed-848e-a03fdb5c0e45 61 fields · synced Oct 6, 2026
- FDA UDI 3a63d520-adb4-4491-8d35-312d4dfc546b 35 fields · synced May 30, 2026