Identity
- Trade Name
- Elóra APS A2 4g EUDAMED
- Device Name
- Elóra APS EUDAMED
- Model / Reference
- 4000056237 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899633834839 EUDAMED
- Basic UDI-DI
- 78996338RST017AF EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Elóra APS A2 4g by Dentscare Ltda — Class IIa — 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 | 78996338RST017AF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dentscare Ltda
- EUDAMED SRN
- BR-MF-000004013
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (1)
- EUDAMED ea762423-c646-42c0-b07b-7abb76d4bb69 61 fields · synced Aug 3, 2026