Identity
- Trade Name
- Mirror handle 28 Esi blue UNF4-48 EUDAMEDLMDental FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- Diagnostic dental hand instrument EUDAMEDMirror handle 28 Esi blue UNF4-48, Diagnostics FDA UDI
- Model / Reference
- 28ESIBLUE EUDAMEDFDA UDI
- Description
- Mirror handle 28 Esi blue UNF4-48, Diagnostics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311211725 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311DIAGNO10QV EUDAMED
- Direct Marketing DI
- 06438311211725 EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental mirror, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mirror handle 28 Esi blue UNF4-48 by LM-Instruments Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438311DIAGNO10QV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED f381e6fc-1fbc-4d11-a467-94429d78f433 61 fields · synced Jul 30, 2026
- FDA UDI b21f9af5-df70-4f97-a924-b5fd36ba4847 33 fields · synced May 30, 2026