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Tüm Yüz (Oranazal) Maske Silikon Esaslı
EUDAMEDClass IIa (EU MDR)
Ref RF01SModel CPAP-BiPAP
Identity
- Trade Name
- Tüm Yüz (Oranazal) Maske Silikon Esaslı EUDAMED
- Device Name
- Continuous Positive Airway Pressure Device EUDAMED
- Model / Reference
- CPAP-BiPAP EUDAMEDRF01S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680845006157 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
Category: Rebreathing oxygen face mask
Tüm Yüz (Oranazal) Maske Silikon Esaslı by Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
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 be90fb65-981a-41ea-930d-87e35aa9b396 61 fields · synced Oct 6, 2026