Vietnam MOH registration 2402762ĐKLH/BYT-HTTB

Grafting of white blood cells, platelet machine and stem cell collection

VN: Kít gạn bạch cầu, tiểu cầu máy và thu nhận tế bào gốc

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Oct 02, 2024

Registration details

Analysis ID: 2402762ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220816-0010
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 Kit for Leukapheresis, Spectra Optia IDL and the collection of stem cells provides an interface between the patient and the automated blood cell separation system Spectra Optia, which is used in applications of blood component separation by machine for treatment. The Spectra Optia IDL Set Kit is designated 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. Please refer to the User Manual of the automated blood cell separation system Spectra Optia for full information on the indications, contraindications, precautions, adverse reactions, clinical benefits, target patient population, and performance characteristics.

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for Grafting of white blood cells, platelet machine and stem cell collection 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 2402762ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ TERUMO VIỆT NAM.

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