Identity
- Trade Name
- KaVo ProXam 3D EUDAMED
- Device Name
- Planmeca ProMax 3D EUDAMED
- Model / Reference
- 30038582 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035420940 EUDAMED
- Basic UDI-DI
- 6430035420105E EUDAMED
- EMDN Code
- Z11030380 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb 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
KaVo ProXam 3D by Planmeca Oy — 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 | 6430035420105E | Class IIb | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (1)
- EUDAMED a8959911-844e-415b-93a8-dc1c24c99cd2 61 fields · synced Jun 18, 2026