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CPAP/BIPAP Masks
EUDAMEDClass IIa (EU MDR)
Ref 05389Model EaseFit FMIModel EaseFit NMI; EaseFit FMI; EaseFit NMI-NV; EaseFit FMI-NV
Identity
- Device Name
- CPAP/BIPAP Masks EUDAMED
- Model / Reference
- EaseFit FMI EUDAMED05389 EUDAMEDEaseFit NMI; EaseFit FMI; EaseFit NMI-NV; EaseFit FMI-NV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949905389 EUDAMED
- Basic UDI-DI
- B-06958949905389 EUDAMED6958949904JE EUDAMED
- EMDN Code
- R0301010201 CPAP 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
CPAP/BIPAP Masks by Hunan Beyond Medical Technology Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06958949905389 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06958949905389 | 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 19e3495f-4371-4c05-b85a-7163db7ed0d7 61 fields · synced Sep 17, 2026
- EUDAMED 4352080c-d086-42cb-ab71-0dc5682add43 61 fields · synced May 17, 2026