Identity
- Device Name
- Planungshilfe Zahnersatz (PZE) EUDAMED
- Model / Reference
- PZE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262377350003 EUDAMED
- Basic UDI-DI
- 426237735DSWINHKPuRNQ EUDAMED
- EMDN Code
- Z12110192 INSTRUMENTS FOR DENTAL TREATMENT UNITS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental x-ray image interpretive software
Planungshilfe Zahnersatz (PZE) by Dampsoft GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426237735DSWINHKPuRNQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dampsoft GmbH
- EUDAMED SRN
- DE-MF-000011427
Sources (1)
- EUDAMED 1d47b78b-c164-46e5-84ce-3a06817c335d 61 fields · synced Jul 22, 2026