Vietnam MOH registration 2402534ĐKLH/BYT-HTTB

Hệ thống đọc kết quả cho xét nghiệm phân tích nhóm máu

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·DiaMed GmbH·Registered Aug 30, 2024

Registration details

Analysis ID: 2402534ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-201021-0030
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: DiaMed GmbH
Manufacturer Country: Theo theo phụ lục
Product Owner: DiaMed GmbH
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI SIXMURS HTH VIỆT NAM

Technical details

Intended Use: Banjo ID-Reader is an automated device designed to read and sort ID cards for the ID system used in hematology immunoassay to determine the ABO blood group (both forward and reverse typing), determine the type of antigen, screen for antibodies, determine and calibrate antibodies, perform direct anti-Globulin test (DAT) and compatibility testing in human blood samples.

Dates and status

Registration Date: Aug 30, 2024

About this record

Access comprehensive regulatory information for Hệ thống đọc kết quả cho xét nghiệm phân tích nhóm máu 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 2402534ĐKLH/BYT-HTTB and manufactured by DiaMed GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI SIXMURS HTH VIỆT NAM.

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