Automated Blood Component Separator - Vietnam Registration 240000372/PCBA-HN
Access comprehensive regulatory information for Automated Blood Component Separator in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000372/PCBA-HN and manufactured by Delcon S.r.l.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM.
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Device Details
Registration Details
240000372/PCBA-HN
000.00.19.H26-240217-0004
Archimede
MOE1504TER
Technical Details
ARCHIMEDE is an automated blood component separation device designated to separate blood components from the fully centrifuged blood contained in single-use blood bags. ARCHIMEDE is designated to process blood bags manufactured according to the international standard ISO 3826. In its characteristics, the device can work with any type of blood bag currently available on the market. ARCHIMEDE is designated to work with blood bags of 450/500mL volume; for other types of blood bags, additional accessories are required. The device is designated for use in the blood bank laboratory and is not intended for use in the blood collection process where the donor/patient is still connected to the needle. The device is not designed to come into contact with blood when used correctly.
Dates and Status
Mar 12, 2024