Vietnam MOH registration 2400676ĐKLH/BYT-HTTB

Automatic Biochemical Analysis Machine.

VN: Máy xét nghiệm sinh hoá tự động.

Vietnam·Risk Class TTBYT Loại C·Selectra Mach5·ELITechGroup B.V.·Registered May 10, 2024

Registration details

Analysis ID: 2400676ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220617-0015
Product Type: Selectra Mach5

Company information

Manufacturer: ELITechGroup B.V.
Manufacturer Country: NETHERLANDS
Product Owner: ELITechGroup B.V.
Authorized Representative: CÔNG TY TNHH VẠN NIÊN

Technical details

Intended Use: Selectra Mach5 is a clinical chemistry system designed to measure analytes in in vitro diagnostic tests of samples taken from the human body. The system is intended for use in clinical laboratories and must be operated by qualified personnel. The system comprises a core module that includes a spectroscopic measurement system.

Dates and status

Registration Date: May 10, 2024

About this record

Access comprehensive regulatory information for Automatic Biochemical Analysis Machine. 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 2400676ĐKLH/BYT-HTTB and manufactured by ELITechGroup B.V.. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.

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.