Manufacturer

Sb-Kawasumi Laboratories

JapanLegal entities : SB-KAWASUMI LABORATORIES, INC.

Markets : France · Germany · Netherlands · United States

Approvals : EU – class IIb · United States (FDA) – 510(k) : 5 · class I, II · latest in 2025 · see on the FDA website

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

1 category, 14 models including 14 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Plasmapheresis devices and kits	B030201	Cascadeflo EC3 refs Plasma Component Separator- Cascadeflo EC EC-20W93/42 Plasma Component Separator- Cascadeflo EC EC-30W93/42 Plasma Component Separator- Cascadeflo EC EC-40W93/42 Plasma Component Separator- Cascadeflo EC EC-50W93/42 9 others Plasma Component Separator- Rheofilter ER ER-400093/42 Plasma Fractionator- Evaflux Evaflux 2A2093/42 Plasma Fractionator- Evaflux Evaflux 3A2093/42 Plasma Fractionator- Evaflux Evaflux 4A2093/42 Plasma Fractionator- Evaflux Evaflux 5A2093/42 Plasma Separator- Evaclio Evaclio EC-2C2093/42 Plasma Separator- Evaclio Evaclio EC-3C2093/42 Plasma Separator- Evaclio Evaclio EC-4C2093/42 Rheofilter ER	IIb MDR, 93/42	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.