Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- 16000004759 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899581345197 EUDAMED
- Basic UDI-DI
- 78995813ScannerAXRSUP EUDAMED
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Intraoral Scanner by Alliage S/A Indústrias Médico Odontológica — 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 | 78995813ScannerAXRSUP | Class I | Active |
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Manufacturer
- Manufacturer
- Alliage S/A Indústrias Médico Odontológica
- EUDAMED SRN
- BR-MF-000016681
- Authorised Representative
- ELS SOLUTIONS GDIA - UNIPESSOAL LDA. PT-AR-000026128
Sources (1)
- EUDAMED 34e81530-418a-4384-a297-077257016ae0 61 fields · synced Jun 19, 2026