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Large Amara Gel Mask with Reduced Size Frame and Headgear International
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1090426Model Amara Gel SE
Identity
- Trade Name
- Large Amara Gel Mask with Reduced Size Frame and Headgear International EUDAMEDAMARA GEL FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- AMARA GEL MASK WITH RS FRAME AND HEADGEAR, LARGE, INTERNATIONAL FDA UDI
- Model / Reference
- Amara Gel SE EUDAMED1090426 EUDAMEDAMARA GEL MASK WITH RS FRAME AND HEADGEAR INTL, LARGE FDA UDI
- Description
- AMARA GEL MASK WITH RS FRAME AND HEADGEAR, LARGE, INTERNATIONAL FDA UDI
Identifiers
- Catalog Number
- 1090426 FDA UDI
- Primary DI / UDI-DI
- 00606959021181 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959021181 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
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
Category: Rebreathing oxygen face mask
Large Amara Gel Mask with Reduced Size Frame and Headgear International by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Rebreathing oxygen face mask.
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- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
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-00606959021181 | 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 75032afa-b305-4b65-894b-66f14e243363 61 fields · synced Jun 18, 2026
- FDA UDI 0d8add30-4870-40bf-9f84-64ed41bc0ff8 36 fields · synced May 29, 2026