Identity
- Trade Name
- KaVo ProXam iS EUDAMED
- Device Name
- Planmeca ProSensor HD EUDAMED
- Model / Reference
- 30038580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035420926 EUDAMED
- Basic UDI-DI
- 6430035420085T EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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 digital imaging sensor, intraoral
KaVo ProXam iS by Planmeca Oy — 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 | 6430035420085T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (1)
- EUDAMED 8c619ee1-42f5-48dd-bf5d-379aed35ce5d 61 fields · synced Jun 19, 2026