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CPAP/BIPAP Mask
EUDAMEDClass IIa (EU MDR)
Ref 09004Model EaseFit FMI-NV, EaseFit FMII-NV EaseFit FMIIP-NV, EaseFit FM3-NV EaseFit FM5-NV, EaseFit FM5A-NV EaseFit NMI-NV, EaseFit NM5-NV EaseFit NM5A-NV, EaseFit NM5B-NV EaseFit NM6-NV, EaseFit NM6A-NV EaseFit NM6B-NV
Identity
- Device Name
- CPAP/BIPAP Mask EUDAMED
- Model / Reference
- EaseFit FMI-NV, EaseFit FMII-NV EaseFit FMIIP-NV, EaseFit FM3-NV EaseFit FM5-NV, EaseFit FM5A-NV EaseFit NMI-NV, EaseFit NM5-NV EaseFit NM5A-NV, EaseFit NM5B-NV EaseFit NM6-NV, EaseFit NM6A-NV EaseFit NM6B-NV EUDAMED09004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949938714 EUDAMED
- Basic UDI-DI
- 6958949957NVZQ EUDAMED
- EMDN Code
- R0301010202 NIV MASKS 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
Category: Rebreathing oxygen face mask
CPAP/BIPAP Mask by Hunan Beyond Medical Technology Co., Ltd. — 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 | 6958949957NVZQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Beyond Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002143
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 25cf72ee-03bc-4e89-956e-67b9c28789d2 61 fields · synced Jun 19, 2026