← Back to catalogue
Companion 5
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 15067021510(k) K121167
by CAIRE Inc.
Identity
- Trade Name
- Companion 5 EUDAMED
- Device Name
- Companion 5 Oxygen Concentrator EUDAMED
- Model / Reference
- 15067021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M766150670210 EUDAMED
- Basic UDI-DI
- B-M766150670210 EUDAMED
- 510(k) Number
- K121167 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Companion 5 by Caire Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121167 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-M766150670210 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CAIRE Inc.
- EUDAMED SRN
- US-MF-000013030
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 5b646f90-c7d2-4cf6-80e8-d14ac8723c6c 61 fields · synced Jul 14, 2026
- FDA 510(k) K121167 24 fields · synced May 18, 2026