Identity
- Trade Name
- KermaX-plus 102-126 TINO EUDAMED
- Device Name
- KermaX Plus EUDAMED
- Model / Reference
- 120-12612 EUDAMED120-12611 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EIBA120126120 EUDAMEDEIBA120126110 EUDAMED
- Basic UDI-DI
- ++EIBAKERMAXPLUSPQ EUDAMED
- Direct Marketing DI
- EIBA120126120 EUDAMEDEIBA120126110 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
KermaX-plus 102-126 TINO 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 | ++EIBAKERMAXPLUSPQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
- EUDAMED SRN
- DE-MF-000006225
Sources (2)
- EUDAMED 5e5f2b9a-1d8b-4bbb-920d-0b536b1267a7 61 fields · synced Oct 6, 2026
- EUDAMED fe71802a-170c-48f2-aeae-733af87eb24d 61 fields · synced May 18, 2026