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CPAP/BIPAP Masks
EUDAMEDClass IIa (EU MDR)
Ref 05594Model EaseFit FMI-NVModel EaseFit NMI; EaseFit FMI; EaseFit NMI-NV; EaseFit FMI-NV
Identity
- Device Name
- CPAP/BIPAP Masks EUDAMED
- Model / Reference
- EaseFit FMI-NV EUDAMED05594 EUDAMEDEaseFit NMI; EaseFit FMI; EaseFit NMI-NV; EaseFit FMI-NV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949905594 EUDAMED
- Basic UDI-DI
- B-06958949905594 EUDAMED6958949904JE EUDAMED
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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 Masks by Hunan Beyond Medical Technology Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06958949905594 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06958949905594 | 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 (2)
- EUDAMED a89db96e-1d6a-4e55-96e3-3123773c0ff3 61 fields · synced Jul 21, 2026
- EUDAMED a323a80b-518e-482e-80b5-c4c1e8b2dd53 61 fields · synced May 18, 2026