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Portux®
EUDAMEDClass IIa (EU MDR)
Ref 0022133 CEModel PMMA MULTI DISC WITH SHOULDER 98.5X16mm A2
by Productora Y Comercializadora Odontologica New Stetic S.a
Identity
- Trade Name
- PORTUX® EUDAMED
- Device Name
- PMMA DISCS FOR CAD/CAM APPLICATION EUDAMED
- Model / Reference
- PMMA MULTI DISC WITH SHOULDER 98.5X16mm A2 EUDAMED0022133 CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07701126713425 EUDAMED
- Basic UDI-DI
- 7701126713425X2 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS 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: Dental appliance fabrication material, resin
Portux® by Productora Y Comercializadora Odontologica New Stetic 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 | 7701126713425X2 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CO-MF-000036727
- Authorised Representative
- Ranelagh Capital SLU ES-AR-000040175
Sources (1)
- EUDAMED 0b90bf92-4a8c-44ec-8f7c-7d636b34c530 61 fields · synced Oct 7, 2026