Vietnam MOH registration 2400616ĐKLH/BYT-HTTB

Automatic Blood Typing Machine

VN: Máy định nhóm máu tự động

Vietnam·Risk Class TTBYT Loại D·ORTHO VISION Analyzer (ORTHO VISION Swift Analyzer)·Tecan Schweiz AG·Registered May 10, 2024

Registration details

Analysis ID: 2400616ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230308-0007
Product Type: ORTHO VISION Analyzer (ORTHO VISION Swift Analyzer)
Product Code: 6904579

Company information

Manufacturer: Tecan Schweiz AG
Manufacturer Country: SWITZERLAND
Product Owner: Ortho-Clinical Diagnostics
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: The machine is used to perform in vitro hemolytic immune testing to identify blood type, hemolytic reactions in blood transfusion, screening and identifying abnormal antibodies, identifying antigens, precipitation tests, control, and antibody calibration.

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Automatic Blood Typing Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2400616ĐKLH/BYT-HTTB and manufactured by Tecan Schweiz AG. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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