Identity
- Trade Name
- SAROS EUDAMEDSaros Oxygen Concentrator FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- SAROS EUDAMEDPortable Oxygen Concentrator 1-3 LPM, Continuous and Pulse Dose Settings FDA UDI
- Model / Reference
- 9400-01-SEQ EUDAMED9400-SEQ FDA UDI
- Description
- Portable Oxygen Concentrator 1-3 LPM, Continuous and Pulse Dose Settings FDA UDI
Identifiers
- Primary DI / UDI-DI
- M766940001SEQ0 EUDAMEDM7669400SEQ0 FDA UDI
- Basic UDI-DI
- B-M766940001SEQ0 EUDAMED
- 510(k) Number
- K083163 FDA UDI
- FDA Product Code
- CAW FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Saros by Caire 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-M766940001SEQ0 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CAIRE Inc.
- EUDAMED SRN
- US-MF-000013030
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 8daee3cb-1780-470c-a7bb-8fc41a776178 61 fields · synced Aug 3, 2026
- FDA UDI f04d4737-a374-4c20-b7fd-0e021499b1f4 34 fields · synced May 25, 2026