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Freestyle Comfort
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AS200-2Ref AS200-2RRef AS200-202
by CAIRE Inc.
Identity
- Trade Name
- Freestyle Comfort EUDAMED
- Device Name
- Freestyle Comfort EUDAMED
- Model / Reference
- AS200-2 EUDAMEDAS200-2R EUDAMEDAS200-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M766AS20020 EUDAMEDM766AS2002R0 EUDAMEDM766AS2002020 EUDAMED
- Basic UDI-DI
- B-M766AS20020 EUDAMEDB-M766AS2002R0 EUDAMEDB-M766AS2002020 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
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
Freestyle Comfort 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 | K250671 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-M766AS20020 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CAIRE Inc.
- EUDAMED SRN
- US-MF-000013030
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (4)
- EUDAMED 418514af-501b-4c0c-9af2-2d713dacb9de 61 fields · synced Sep 18, 2026
- EUDAMED 73a414d0-4213-4327-bb53-c8c63f792981 61 fields · synced May 18, 2026
- EUDAMED ce688e04-9728-4ca3-880a-d2152ce55c5d 61 fields · synced May 19, 2026
- FDA 510(k) K250671 1 fields · synced May 18, 2026