Vietnam MOH registration 2401189ĐKLH/BYT-HTTB

Control Material for 13 Gas Blood, Electrolyte and Metabolite Tests

VN: Vật liệu kiểm soát xét nghiệm 13 thông số khí máu, điện giải và chất chuyển hóa

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Eurotrol B.V.·Registered Jul 22, 2024

Registration details

Analysis ID: 2401189ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211210-0022
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Eurotrol B.V.
Manufacturer Country: Theo theo phụ lục
Product Owner: Eurotrol B.V.
Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: Eurotrol epoc GAS-ISE Metabolites is a single-use reference standard used in the qualitative determination of concentration and accuracy of the epoc Blood Analysis System for the metabolites, electrolytes, and blood gases. This product is an in vitro diagnostic device (in vitro), intended for use by qualified laboratory personnel. Eurotrol epoc GAS-ISE Metabolites is designed to measure the concentrations of the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.

Dates and status

Registration Date: Jul 22, 2024

About this record

Access comprehensive regulatory information for Control Material for 13 Gas Blood, Electrolyte and Metabolite Tests 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 2401189ĐKLH/BYT-HTTB and manufactured by Eurotrol B.V.. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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