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Round Excavator 2.0mm Orbis
EUDAMEDClass I (EU MDR)
Ref 65-66PDOLMModel Dental hand instrument, excavator for the removal of softened carious dentin
Identity
- Trade Name
- Round Excavator 2.0mm Orbis EUDAMED
- Device Name
- Restorative hand instrument Ir EUDAMED
- Model / Reference
- 65-66PDOLM EUDAMEDDental hand instrument, excavator for the removal of softened carious dentin EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706610 EUDAMED
- Basic UDI-DI
- 6438311RESTO1r0C6 EUDAMEDB-06438311706610 EUDAMED
- Direct Marketing DI
- 06438311706610 EUDAMED
- EMDN Code
- L159002 DENTAL EXCAVATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Round Excavator 2.0mm Orbis by LM-Instruments Oy — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438311RESTO1r0C6 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311RESTO1r0C6 | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED ed3e724d-48da-4dab-8c1c-7559f8f2d9ad 61 fields · synced Jul 19, 2026
- EUDAMED 56f0d034-7a75-4f69-9d8c-fe686d1be495 61 fields · synced May 19, 2026