Identity
- Trade Name
- CPAP mask EUDAMEDHanwell FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- CPAP mask EUDAMEDContinuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure to treat obstructive sleep apnea(OSA), hypopnea, air flow restrictions and snoring. Made from medical grade Silicone, have good biocompatibility. Provide a good seal when fitted to the patient. Features a 360 degree dual swivel elbow port to move freely. The ultra-flexible forehead support reduces contact with your skin. FDA UDI
- Model / Reference
- HY-008-3 EUDAMEDL FDA UDI
- Description
- Continuous Positive Airway Pressure (CPAP) mask provides the continuous positive airway pressure to treat obstructive sleep apnea(OSA), hypopnea, air flow restrictions and snoring. Made from medical grade Silicone, have good biocompatibility. Provide a good seal when fitted to the patient. Features a 360 degree dual swivel elbow port to move freely. The ultra-flexible forehead support reduces contact with your skin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975834950583 EUDAMEDFDA UDI
- Basic UDI-DI
- 697583495CPAPSUA EUDAMED
- FDA Product Code
- BYF FDA UDI
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5600 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CPAP mask by Ningbo Hanyue Medical Technology CO., LTD. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697583495CPAPSUA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Hanyue Medical Technology CO., LTD.
- EUDAMED SRN
- CN-MF-000035941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 881e4137-ffbe-4a0a-8a10-6549d09b3b02 61 fields · synced Aug 3, 2026
- FDA UDI 1d591561-6f6d-41e2-9202-3d2faa6e8a82 33 fields · synced May 29, 2026