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Cascadeflo EC
EUDAMEDClass IIb (EU MDR)
Ref EC-40WRef EC-50WRef EC-20WRef EC-30W
Identity
- Trade Name
- Cascadeflo EC EUDAMED
- Device Name
- Plasma Component Separator EUDAMED
- Model / Reference
- EC-40W EUDAMEDEC-50W EUDAMEDEC-20W EUDAMEDEC-30W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488102159 EUDAMED04987488102166 EUDAMED04987488102135 EUDAMED04987488102142 EUDAMED
- Basic UDI-DI
- 4987488PCS_EC_PW EUDAMED
- EMDN Code
- B030201 PLASMAPHERESIS DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cascadeflo EC by Sb-Kawasumi Laboratories, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4987488PCS_EC_PW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sb-Kawasumi Laboratories, Inc.
- EUDAMED SRN
- JP-MF-000011253
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED a3bc0a9a-fc7d-4dcf-8498-dad3f412bbf8 61 fields · synced Jul 21, 2026
- EUDAMED 6b996d0c-8f62-4b3f-b762-4a0566bd3929 61 fields · synced May 17, 2026
- EUDAMED b3b61359-25bb-43ea-afaa-d48127ae9aac 61 fields · synced May 18, 2026
- EUDAMED 6351f8a4-f967-45ac-9378-4b0e198b7e67 61 fields · synced May 18, 2026