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Medium Comfort Classic with Headgear - Iberia
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1007968Model ComfortClassic Nasal Mask
Identity
- Trade Name
- Medium Comfort Classic with Headgear - Iberia EUDAMEDComfort Classic FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Comfort Classic Mask with Headgear, Medium, Iberia FDA UDI
- Model / Reference
- ComfortClassic Nasal Mask EUDAMED1007968 EUDAMEDComfort Classic Mask with Headgear, Medium , Iberia FDA UDI
- Description
- Comfort Classic Mask with Headgear, Medium, Iberia FDA UDI
Identifiers
- Catalog Number
- 1007968 FDA UDI
- Primary DI / UDI-DI
- 00606959023161 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959023161 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
Category: Rebreathing oxygen face mask
Medium Comfort Classic with Headgear - Iberia 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-00606959023161 | 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 (3)
- EUDAMED b80f3872-8b9f-499a-abe5-18999c046aef 61 fields · synced Aug 4, 2026
- FDA UDI b18285ec-06ed-4cdc-8ec3-52dead2b7812 36 fields · synced May 30, 2026
- EUDAMED 8a778f03-0e26-457c-be4d-9722b4e6c115 61 fields · synced Aug 4, 2026