Identity
- Trade Name
- ELEPHANDENS EUDAMED
- Model / Reference
- Artificial Teeth EUDAMEDM8B2M34S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435288486109 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
Elephandens by Union Dental S.a. — 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 | 084352884UD-TEETHVS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Union Dental S.a.
- EUDAMED SRN
- ES-MF-000003189
Sources (1)
- EUDAMED 143387bf-01a4-473e-a7ef-d19c83dc4d35 61 fields · synced Jul 25, 2026