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Nazal (burun) Maske Si̇li̇kon Esasli
EUDAMEDClass IIa (EU MDR)
Ref RNXModel CPAP-BiPAP
Identity
- Trade Name
- NAZAL (BURUN) MASKE SİLİKON ESASLI EUDAMED
- Device Name
- Continuous Positive Airway Pressure Device EUDAMED
- Model / Reference
- CPAP-BiPAP EUDAMEDRNX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680845006478 EUDAMED
- Basic UDI-DI
- 868407208MASKM3 EUDAMED
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nazal (burun) Maske Si̇li̇kon Esasli by Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş. — 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 | 868407208MASKM3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.
- EUDAMED SRN
- TR-MF-000017200
Sources (1)
- EUDAMED 59140873-be13-41c9-85a2-a2f34e768a72 61 fields · synced Oct 6, 2026