Identity
- Trade Name
- Planmeca Somia EUDAMED
- Device Name
- Intraoral Camera EUDAMED
- Model / Reference
- 30015458 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800096901401 EUDAMED
- Basic UDI-DI
- 88000969IOC01LG EUDAMED
- EMDN Code
- Z12119080 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Planmeca Somia by Dentall co., Ltd. — Class I — 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 | 88000969IOC01LG | Class I | Active |
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Manufacturer
- Manufacturer
- DENTALL Co., Ltd.
- EUDAMED SRN
- KR-MF-000013640
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 087bf4cf-6883-437e-a517-999a6de963fb 61 fields · synced Jun 18, 2026