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Splendid®
EUDAMEDClass IIa (EU MDR)
Ref 54011 CEModel Splendid® Two layers, Set x 8 piecesRef 54010 CEModel Splendid® Two layers, Set x 6 pieces
by Productora Y Comercializadora Odontologica New Stetic S.a
Identity
- Trade Name
- Splendid® EUDAMED
- Device Name
- Acrylic resin teeth EUDAMED
- Model / Reference
- Splendid® Two layers, Set x 8 pieces EUDAMED54011 CE EUDAMEDSplendid® Two layers, Set x 6 pieces EUDAMED54010 CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07701126550464 EUDAMED07701126550457 EUDAMED
- Basic UDI-DI
- 7701126550464X9 EUDAMED7701126550457XC EUDAMED
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
Classification
- Device Class
- Class IIa 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
Splendid® by Productora Y Comercializadora Odontologica New Stetic 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 | 7701126550464X9 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CO-MF-000036727
- Authorised Representative
- Ranelagh Capital SLU ES-AR-000040175
Sources (2)
- EUDAMED e0c43759-78b1-4f27-af63-07e1dd68373a 61 fields · synced Oct 7, 2026
- EUDAMED c2637441-decb-449c-8230-8a017736a898 61 fields · synced May 17, 2026