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Planmeca Viso 2D Pro
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 30051741
by Planmeca Oy
Identity
- Trade Name
- Planmeca Viso 2D Pro EUDAMED
- Device Name
- Planmeca Viso 2D EUDAMED
- Model / Reference
- 30051741 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035421060 EUDAMED
- Basic UDI-DI
- 6430035420255T 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Planmeca Viso 2D Pro by Planmeca Oy — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181576 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K230985 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 6430035420255T | Class IIb | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
- EUDAMED SRN
- FI-MF-000006499
Sources (2)
- EUDAMED 6a91a563-244b-4d6b-8054-e610a3268d6d 61 fields · synced Jun 19, 2026
- FDA 510(k) K181576 1 fields · synced May 18, 2026