Identity
- Trade Name
- LoreSmile EUDAMED
- Device Name
- Disposable Protective Liner EUDAMED
- Model / Reference
- SML011-PL01 EUDAMEDSML011-PL02/ LS11SMILE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897129991373 EUDAMED
- Basic UDI-DI
- 489712999PL5G EUDAMED
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
LoreSmile by SML Med-Tech Solutions Limited — 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 | 489712999PL5G | Class I | Active |
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Manufacturer
- Manufacturer
- SML Med-Tech Solutions Limited
- EUDAMED SRN
- CN-MF-000031313
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED c1ceccb4-916f-4e20-aff7-c72d22518d4e 61 fields · synced Jul 22, 2026