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UltraSmart plus Cube touch
EUDAMEDClass I (EU MDR)
Ref 078390T plusModel LED Ultra Smart 2
Identity
- Trade Name
- UltraSmart plus Cube touch EUDAMED
- Device Name
- LED Ultra Smart 2 EUDAMED
- Model / Reference
- LED Ultra Smart 2 EUDAMED078390T plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262393580033 EUDAMED
- Basic UDI-DI
- 426239358001B4 EUDAMED
- Direct Marketing DI
- 04262393580033 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
Category: Dental/surgical polymerization lamp
UltraSmart plus Cube touch by Sigma Dental Systems - Emasdi GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 778e25c4-9044-4ad0-9885-e92d84f9a095 61 fields · synced Jul 13, 2026