Identity
- Trade Name
- Flexplorer ErgoMax (With Compliments) EUDAMED
- Device Name
- Diagnostic dental hand instrument EUDAMED
- Model / Reference
- 99911F12FXSI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311226958 EUDAMED
- Basic UDI-DI
- 6438311DIAGNO10QV EUDAMED
- Direct Marketing DI
- 06438311226958 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
Flexplorer ErgoMax (With Compliments) 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 6b1a8cd8-0999-4f59-aae9-6c4b54770c22 61 fields · synced Jun 20, 2026