Cascadeflo EC
by Sb-Kawasumi Laboratories, Inc. United States EUDAMED
Ref EC-20W
EMDN B030201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4987488PCS_EC_PW | Date8 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Plasma Component Separator
- Model / Reference
- EC-20W
- Primary DI / UDI-DI
- 04987488102135
- Basic UDI-DI
- 4987488PCS_EC_PW
- EMDN Code
- B030201 Plasmapheresis devices and kits
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000011253
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Sb-Kawasumi Laboratories, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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 b3b61359-25bb-43ea-afaa-d48127ae9aac