Carilex
by Carilex Medical, Inc United States EUDAMED
Ref S2201-3015Model TheraFlo AP
EMDN V080701
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471987369S2XXXS4 | Date4 Feb 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Anti-decubitus Air Alternating Pressure Device and System with Accessories
- Model / Reference
- TheraFlo AP, S2201-3015
- Primary DI / UDI-DI
- 04719873691258
- Basic UDI-DI
- 471987369S2XXXS4
- Direct Marketing DI
- 04719873691258
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000002145
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Carilex Medical, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: 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
Sources (1)
- EUDAMED 45ecc958-e158-416a-9184-e81d5e66c48c