Red blood cell collection, plasma - Vietnam Registration 2403642ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Red blood cell collection, plasma in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403642ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM.
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Device Details
Registration Details
2403642ĐKLH/BYT-HTTB
000.00.04.G18-220516-0031
Theo theo phụ lục
Theo phụ lục
Technical Details
Red blood cell collection kit, compatible with Trima Accel, an automated blood cell separation system. The kit is used to collect blood and/or red blood cells. •No full studies have been performed to evaluate the quality of gamma irradiation or freezing of red blood cells obtained by ACD-A/AS-3 in the Trima Accel system after the TLR filtration process. •No studies have been performed to support gamma irradiation or freezing of red blood cells ACD-A/AS-3 collected with the Auto RBC filter in the RBC collection pathway (Auto RBC filter) on the Trima Accel system. The red blood cell collection kit, compatible with Trima Accel, is intended for the routing and collection of blood components from the intervention site through the Trima Accel automated blood cell separation system. Please read the Trima Accel Automated Blood Cell Separation System Operations Manual for a complete list of contraindications, warnings, precautions, adverse reactions, operational instructions, clinical benefits, and performance characteristics of the Trima Accel system.
Dates and Status
Nov 19, 2024

