Vietnam MOH registration 2402840ĐKLH/BYT-HTTB

Plasma Exchange, Red Blood Cells

VN: Kít trao đổi huyết tương, hồng cầu

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Oct 22, 2024

Registration details

Analysis ID: 2402840ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230401-0006
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: 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

Registration Date: Oct 22, 2024

About this record

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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