Identity
- Trade Name
- Mirror handle 28 ES red UNF4-48 DTS U EUDAMED
- Device Name
- Diagnostic dental hand instrument EUDAMED
- Model / Reference
- 28ESREDTU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311001364 EUDAMED
- Basic UDI-DI
- 6438311DIAGNO10QV EUDAMED
- Direct Marketing DI
- 06438311001364 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
Mirror handle 28 ES red UNF4-48 DTS U 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 (1)
- EUDAMED 1206b614-8c48-4b45-a93e-f689fac89141 61 fields · synced Jul 9, 2026