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Profile Lite 2 SE with Headgear, Petite, Italy
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1132188
Identity
- Trade Name
- Profile Lite 2 SE with Headgear, Petite, 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, Petite, Italy FDA UDI
- Model / Reference
- 1132188 EUDAMEDProfile Lite 2 SE with Headgear, Petite, Italy FDA UDI
- Description
- Profile Lite 2 SE with Headgear, Petite, Italy FDA UDI
Identifiers
- Catalog Number
- 1132188 FDA UDI
- Primary DI / UDI-DI
- 00606959044227 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959044227 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
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
Profile Lite 2 SE with Headgear, Petite, Italy by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00606959044227 | 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 4b235d04-f8e3-430e-addb-36d29409dbba 61 fields · synced Jun 19, 2026
- FDA UDI 9f066d8d-e492-4b02-b0eb-af1d11e79b91 36 fields · synced May 30, 2026
- EUDAMED c5021fde-3724-4a17-a935-b9a76837d1b0 61 fields · synced Jun 19, 2026