Identity
- Trade Name
- CPAP Face Mask Set w/Hose, M EUDAMEDN/A FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- Disposable CPAP Mask EUDAMEDCPAP Face Mask Set w/Hose, M FDA UDI
- Model / Reference
- AM0121 EUDAMEDFDA UDI
- Description
- CPAP Face Mask Set w/Hose, M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06923980110498 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801ND2HAP3 EUDAMED
- 510(k) Number
- K072755 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
CPAP Face Mask Set w/Hose, M by GaleMed (Xiamen) 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 | 69239801ND2HAP3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c4f14ab9-65d6-4ec3-a9ea-2717c6fb5439 61 fields · synced Aug 4, 2026
- FDA UDI 7988be1c-facf-4e80-bf97-976841da0aa6 34 fields · synced May 30, 2026