Profile Lite 2 SE with Headgear, Medium, Italy
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Profile Lite 2 SE with Headgear, Medium, Italy EUDAMEDPROFILE LITE 2 FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- ComfortGel Blue / ProFile Lite Family EUDAMEDProfile Lite 2 SE with Headgear, Medium, Italy FDA UDI
- Model / Reference
- 1132186 EUDAMEDProfile Lite 2 SE with Headgear, Medium, Italy FDA UDI
- Description
- Profile Lite 2 SE with Headgear, Medium, Italy FDA UDI
Identifiers
- Catalog Number
- 1132186 FDA UDI
- Primary DI / UDI-DI
- 00606959044197 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959044197 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
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Rebreathing oxygen face mask
Profile Lite 2 SE with Headgear, Medium, Italy by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959044197 | 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 89b7502e-aa59-47e2-b2af-a5b19036319e 61 fields · synced Aug 1, 2026
- FDA UDI dcf2a012-49e4-4e46-b35e-1547f94dbe0d 36 fields · synced May 30, 2026
- EUDAMED ed9170f8-3b97-40de-bf22-b6cb850f8b86 61 fields · synced Aug 1, 2026