Identity
- Trade Name
- ELEPHANDENS EUDAMED
- Model / Reference
- Artificial Teeth EUDAMEDM8B3S6S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435288486420 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 caa5a3a6-4825-4cd0-a042-624214ffba31 61 fields · synced Jul 11, 2026