Identity
- Trade Name
- Elóra APS A3.5 4g EUDAMED
- Device Name
- Elóra APS EUDAMED
- Model / Reference
- 4000056241 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899633834853 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
Category: Dental composite resin
Elóra APS A3.5 4g by Dentscare Ltda — Class IIa — 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 | 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 b38b7e9c-5d7a-49cf-a2fe-881ea86f4897 61 fields · synced Jul 9, 2026