Vietnam MOH registration 2400178ĐKLH/BYT-HTTB

Machine for determining blood type/automated antibody screening

VN: Máy định nhóm máu/sàng lọc kháng thể tự động

Vietnam·Risk Class TTBYT Loại D·Erytra Eflexis·Diagnostic Grifols, S.A.·Registered Feb 04, 2024

Registration details

Analysis ID: 2400178ĐKLH/BYT-HTTB
Submission ID: 19010239/ĐKLH-BYT-TB-CT
Product Type: Erytra Eflexis
Product Code: 210600

Company information

Manufacturer: Diagnostic Grifols, S.A.
Manufacturer Country: SPAIN
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: Erytra Eflexis is a fully automated blood analysis system, designed to automate the in vitro hemolytic immune testing of human blood samples according to the gel card technology, including blood group determination, antigen typing, antibody screening, antibody identification, hemolysis testing, and direct anti-globulin testing. It is an independent testing instrument or can be connected to the customer's laboratory information system (LIS), Erytra Eflexis automates the testing procedures and data management requirements using the gel card technology of Grifols and performs digital image processing.

Dates and status

Registration Date: Feb 04, 2024

About this record

Access comprehensive regulatory information for Machine for determining blood type/automated antibody screening 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 2400178ĐKLH/BYT-HTTB and manufactured by Diagnostic Grifols, S.A.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.