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Biodent®
EUDAMEDClass IIa (EU MDR)
Ref 42010 CEModel Biodent® Set x 6 pieces
by Productora Y Comercializadora Odontologica New Stetic S.a
Identity
- Trade Name
- Biodent® EUDAMED
- Device Name
- Acrylic resin teeth EUDAMED
- Model / Reference
- Biodent® Set x 6 pieces EUDAMED42010 CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07701126550327 EUDAMED
- Basic UDI-DI
- 7701126550327WW 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
Category: Partial denture
Biodent® by Productora Y Comercializadora Odontologica New Stetic S A — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Partial denture.
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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 | 7701126550327WW | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CO-MF-000036727
- Authorised Representative
- Ranelagh Capital SLU ES-AR-000040175
Sources (1)
- EUDAMED aab9532e-6ea2-4647-b6f4-1e0ad2d5e518 61 fields · synced Oct 7, 2026