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Amara View Mask without Headgear, Medium
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1090613
Identity
- Trade Name
- Amara View Mask without Headgear, Medium EUDAMEDAmara View FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Amara View Minimal Contact EUDAMEDAmara View Mask without Headgear, Medium FDA UDI
- Model / Reference
- 1090613 EUDAMEDAmara View Mask without Headgear, Medium FDA UDI
- Description
- Amara View Mask without Headgear, Medium FDA UDI
Identifiers
- Catalog Number
- 1090613 FDA UDI
- Primary DI / UDI-DI
- 00606959009172 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959009172 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rebreathing oxygen face mask
Amara View Mask without Headgear, Medium by Respironics Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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-00606959009172 | 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 0ab8c647-20aa-4dea-9e7c-e9de2340fb20 61 fields · synced Jul 10, 2026
- FDA UDI 4adb09e7-1301-42ab-8eeb-a86d121cba20 36 fields · synced May 30, 2026