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M, DreamWear Silicone Pillows, Medium Frame with Headgear, Asian Pacific
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1146415APModel DreamWear Silicone Pillows Mask
Identity
- Trade Name
- M, DreamWear Silicone Pillows, Medium Frame with Headgear, Asian Pacific EUDAMEDDreamWear FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Medium, DreamWear Silicone Pillows, Medium Frame with Headgear, Asian Pacific FDA UDI
- Model / Reference
- DreamWear Silicone Pillows Mask EUDAMED1146415AP EUDAMEDDreamWear Silicone Pillows, Medium, Medium Frame with Headgear, Asian Pacific FDA UDI
- Description
- Medium, DreamWear Silicone Pillows, Medium Frame with Headgear, Asian Pacific FDA UDI
Identifiers
- Catalog Number
- 1146415AP FDA UDI
- Primary DI / UDI-DI
- 00606959062115 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959062115 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010202 NIV 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
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
M, DreamWear Silicone Pillows, Medium Frame with Headgear, Asian Pacific by Respironics Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959062115 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 1e2759a0-2c3b-42c6-823e-aa7609c1e9e4 61 fields · synced Jul 19, 2026
- FDA UDI 299dd1bc-b223-4c94-84a6-13260d08987b 36 fields · synced May 30, 2026