Identity
- Trade Name
- Explorer Orbis EUDAMED
- Device Name
- Diagnostic dental hand instrument EUDAMED
- Model / Reference
- 5-8PDOLM EUDAMED5-9PDLM EUDAMED17-23PDLM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706382 EUDAMED06438311706719 EUDAMED06438311706726 EUDAMED
- Basic UDI-DI
- 6438311DIAGNO10QV EUDAMED
- Direct Marketing DI
- 06438311706382 EUDAMED06438311706719 EUDAMED06438311706726 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
Explorer Orbis by LM-Instruments Oy — 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 | 6438311DIAGNO10QV | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (3)
- EUDAMED ee1ae3ee-4ebf-49a7-9e3c-31b6bcd46c47 61 fields · synced Jul 25, 2026
- EUDAMED 610a25bb-67e8-4594-8ab3-7ab63116af21 61 fields · synced May 17, 2026
- EUDAMED 59baeb58-96ee-4252-a849-86d2d977c8ce 61 fields · synced May 17, 2026