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SMART Guide Szoftverrendszer 3.0
EUDAMEDClass IIb (EU MDR)
Ref (8012)000003000003000003
by Dicomlab Dental Kutatás-fejlesztési Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
Identity
- Trade Name
- SMART Guide Szoftverrendszer 3.0 EUDAMED
- Device Name
- SMART Guide Szoftverrendszer 3.0 EUDAMED
- Model / Reference
- (8012)000003000003000003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05999861733002 EUDAMED
- Basic UDI-DI
- 5999861733SW01RL EUDAMED
- EMDN Code
- Z12110192 INSTRUMENTS FOR DENTAL TREATMENT UNITS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental x-ray image interpretive software
SMART Guide Szoftverrendszer 3.0 by Dicomlab Dental Kutatás-fejlesztési Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság — Class IIb — MDR — listed…
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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 | 5999861733SW01RL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dicomlab Dental Kutatás-fejlesztési Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
- EUDAMED SRN
- HU-MF-000014062
Sources (1)
- EUDAMED 85be6483-0f27-4c72-9478-857b8538f363 61 fields · synced Jul 9, 2026