Purema® H Hemoconcentrator (EtO Sterilized)

Purema® H Hemoconcentrator (EtO Sterilized) is an FDA 510(k)-cleared medical device (K232171) manufactured by Tecnoideal America. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 2024. Regulation: 8.