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iQ Blue Nasal Mask with iQ 3 Point Headgear
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 50647
Identity
- Trade Name
- iQ Blue Nasal Mask with iQ 3 Point Headgear EUDAMEDFDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Nasal Mask EUDAMEDNasal vented mask for use in positive pressure ventilation. FDA UDI
- Model / Reference
- 50647 EUDAMEDFDA UDI
- Description
- Nasal vented mask for use in positive pressure ventilation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814747022863 EUDAMEDFDA UDI
- Basic UDI-DI
- 814747021004CG EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP nasal mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Netherlands 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
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
iQ Blue Nasal Mask with iQ 3 Point Headgear by Sleepnet Corporation — 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 | 814747021004CG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
- EUDAMED SRN
- US-MF-000010620
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 46a50a38-7e7b-4fa7-a2b5-f361e2ac8bb3 61 fields · synced Jun 9, 2026
- FDA UDI 9d4e28dd-4d40-465a-991e-013d6154f6f0 34 fields · synced May 30, 2026