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Portux®
EUDAMEDClass IIa (EU MDR)
Ref 0021942 CEModel PMMA MONO DISC WITH SHOULDER 98.5X18mm B1
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 MONO DISC WITH SHOULDER 98.5X18mm B1 EUDAMED0021942 CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07701126712435 EUDAMED
- Basic UDI-DI
- 7701126712435WW EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS 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
A comprehensive medical device directory entry for the PORTUX®, a Class IIa medical device.
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 | 7701126712435WW | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CO-MF-000036727
- Authorised Representative
- Ranelagh Capital SLU ES-AR-000040175
Sources (1)
- EUDAMED e446c2d2-dfb3-4c2d-8e5d-23fb89070793 61 fields · synced Oct 6, 2026