← Back to catalogue
Fullface (oranazal) Maske Si̇li̇kon Esasli Hava Kaçaksiz Medium
EUDAMEDClass IIa (EU MDR)
Ref RF02MModel CPAP-BiPAP
Identity
- Trade Name
- FULLFACE (ORANAZAL) MASKE SİLİKON ESASLI HAVA KAÇAKSIZ MEDIUM EUDAMED
- Device Name
- Continuous Positive Airway Pressure Device EUDAMED
- Model / Reference
- CPAP-BiPAP EUDAMEDRF02M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680845006379 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
Fullface (oranazal) Maske Si̇li̇kon Esasli Hava Kaçaksiz Medium by Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş. — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Rebreathing oxygen face mask.
- DUAL MASK-ADULT MALE NOSE CLIP MC WITH CO2 MONIT 7FT (USA) — FLEXICARE MEDICAL LIMITED · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I
- Ventlab — Ventlab Corp. · Class I
- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.
- EUDAMED SRN
- TR-MF-000017200
Sources (1)
- EUDAMED 6117b1ee-140d-4d89-8a32-d5c5c1eb1277 61 fields · synced Oct 6, 2026