Plasma Exchange, Red Blood Cells - Vietnam Registration 2402840ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Plasma Exchange, Red Blood Cells 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 2402840ĐKLH/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
2402840ĐKLH/BYT-HTTB
000.00.04.G18-230401-0006
Theo theo phụ lục
Theo phụ lục
Technical Details
The Spectra Optia® Exchange Set, which facilitates the exchange of blood components, comprises the interface between the patient and the automated blood cell separation system Spectra Optia, which is used in blood component separation applications performed by machines for treatment. The Exchange Set is indicated to guide the blood components from the intervention site through the automated blood cell separation system Spectra Optia and back into the patient's body. For a complete manual of the automated blood cell separation system Spectra Optia, including information on indications, contraindications, precautions, adverse reactions, clinical benefits, target patient population, and performance characteristics, please refer to the manual of the automated blood cell separation system Spectra Optia.
Dates and Status
Oct 22, 2024