Vietnam MOH registration 2403642ĐKLH/BYT-HTTB

Red blood cell collection, plasma

VN: Kít thu nhận hồng cầu, huyết tương

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 19, 2024

Registration details

Analysis ID: 2403642ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220516-0031
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Nov 19, 2024

About this record

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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