Vietnam MOH registration 240002180/PCBB-HN

Automated Blood Gas and Electrolyte Analyzer

VN: Máy xét nghiệm khí máu và điện giải tự động

Vietnam·Risk Class TBYT Loại B·ESCHWEILER modular pro BGA+ISE+META·ESCHWEILER GmbH & Co. KG·Registered Aug 26, 2024

Registration details

Analysis ID: 240002180/PCBB-HN
Submission ID: 000.00.19.H26-240823-0017
Product Type: ESCHWEILER modular pro BGA+ISE+META

Company information

Manufacturer: ESCHWEILER GmbH & Co. KG
Product Owner: ESCHWEILER GmbH & Co. KG
Authorized Representative: CÔNG TY TNHH Y TẾ MINH NHẬT

Technical details

Intended Use: The ESCHWEILER module pro is an automated measurement system controlled by a microprocessor, with the calibration solutions relevant to the system being components of the system, and are used to determine the quantitative and calculate the blood gas, electrolyte, t-Hemoglobin (tHb) and metabolites from whole blood, serum or plasma of human. The Modular pro was produced for clinical and specialized medical use by the experts in In Vitro diagnosis.

Dates and status

Registration Date: Aug 26, 2024

About this record

Access comprehensive regulatory information for Automated Blood Gas and Electrolyte Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002180/PCBB-HN and manufactured by ESCHWEILER GmbH & Co. KG. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINH NHẬT.

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