Identity
- Trade Name
- ELEPHANDENS EUDAMED
- Model / Reference
- Artificial Teeth EUDAMEDM8D3M42I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435288487595 EUDAMED
- Basic UDI-DI
- 084352884UD-TEETHVS EUDAMED
- EMDN Code
- Q01020601,Q01020602,Q01020603,Q01020605 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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: Resin artificial teeth
Elephandens by Union Dental S.a. — 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 | 084352884UD-TEETHVS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Union Dental S.a.
- EUDAMED SRN
- ES-MF-000003189
Sources (1)
- EUDAMED e98ef09e-d001-474b-b35c-f112414eb294 61 fields · synced Jul 29, 2026