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CPAP/BIPAP Masks
EUDAMEDClass IIa (EU MDR)
Ref 09001Model EaseFit FMI, EaseFit FMII EaseFit FMIIP, EaseFit FM3 EaseFit FM5, EaseFit FM5A EaseFit NMI, EaseFit PMI EaseFit NM5, EaseFit NM5A EaseFit NM5B, EaseFit NM6 EaseFit NM6A, EaseFit NM6B
Identity
- Device Name
- CPAP/BIPAP Masks EUDAMED
- Model / Reference
- EaseFit FMI, EaseFit FMII EaseFit FMIIP, EaseFit FM3 EaseFit FM5, EaseFit FM5A EaseFit NMI, EaseFit PMI EaseFit NM5, EaseFit NM5A EaseFit NM5B, EaseFit NM6 EaseFit NM6A, EaseFit NM6B EUDAMED09001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949938684 EUDAMED
- Basic UDI-DI
- 6958949957K3 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Cyprus 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
CPAP/BIPAP Masks by Hunan Beyond Medical Technology Co., Ltd. — 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 | 6958949957K3 | 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 ea53adc8-1c0d-4e43-b6e8-f4cb3293c0fa 61 fields · synced Aug 2, 2026