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UltraSmart Plusn Study
EUDAMEDClass I (EU MDR)
Ref 078380M plusModel LED Ultra Smart 2
Identity
- Trade Name
- UltraSmart Plusn Study EUDAMED
- Device Name
- LED Ultra Smart 2 EUDAMED
- Model / Reference
- LED Ultra Smart 2 EUDAMED078380M plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262393580026 EUDAMED
- Basic UDI-DI
- 426239358001B4 EUDAMED
- Direct Marketing DI
- 04262393580026 EUDAMED
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT 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
UltraSmart Plusn Study by Sigma Dental Systems - Emasdi GmbH — 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 | 426239358001B4 | Class I | Active |
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Manufacturer
- Manufacturer
- Sigma Dental Systems - Emasdi GmbH
- EUDAMED SRN
- DE-MF-000011719
Sources (1)
- EUDAMED d0b4a793-2f7b-495a-b7dd-3f0108eb2d84 61 fields · synced Jun 18, 2026