Identity
- Trade Name
- ELEPHANDENS EUDAMED
- Model / Reference
- Artificial Teeth EUDAMEDM8C4M23S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435288487168 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
Similar devices
Also classified as Resin artificial teeth.
- Resin Teeth / DCL / PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
- Candulor NFC+ — Candulor AG · Class II
- Physioset TCR 6er — Candulor AG · Class II
- Portrait® IPN® Anteriors — Dentsply International · Class II
- artegral life — Merz Dental GmbH · Class II
- Mondial 8i, D4 / M, CE — Kulzer, Inc. · Class II
- Monarch — Wright Health Group , Ltd. · Class II
- Ref-Line — POLIDENT d.o.o. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Union Dental S.a.
- EUDAMED SRN
- ES-MF-000003189
Sources (1)
- EUDAMED bb86cd31-7c1a-4e64-b92e-da86dba1f7b3 61 fields · synced Jun 18, 2026