Identity
- Trade Name
- Composite Spatula 6 Orbis EUDAMED
- Device Name
- Restorative dental hand instrument EUDAMED
- Model / Reference
- 446-447PDLM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706887 EUDAMED
- Basic UDI-DI
- 6438311RESTO102Y EUDAMED
- Direct Marketing DI
- 06438311706887 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION 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
Composite Spatula 6 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 | 6438311RESTO102Y | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (1)
- EUDAMED bea9b71f-06ad-430d-9ede-d89a5b7f8c99 61 fields · synced Aug 1, 2026