Vietnam MOH registration 240000536/PCBA-HCM

Mobile Molecular Diagnostic Workstation

VN: Máy trạm phân tử di động

Vietnam·Risk Class TTBYT Loại A·Portable Molecule Workstation·Sansure Biotech Inc.·Registered Apr 05, 2024

Registration details

Analysis ID: 240000536/PCBA-HCM
Submission ID: 000.00.19.H29-240326-0013
Product Type: Portable Molecule Workstation
Product Code: S-Q31B

Company information

Manufacturer: Sansure Biotech Inc.
Manufacturer Country: CHINA
Product Owner: Sansure Biotech Inc.
Authorized Representative: CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM

Technical details

Intended Use: The portable molecular diagnostic station is used in conjunction with the relevant drug test produced by Sansure Biotech Inc. Based on the polymerase chain reaction (PCR) technology, the device can be used to extract, amplify, quantitatively and qualitatively analyze the nucleic acids (DNA/RNA) present in the samples from human body. For in vitro diagnostic use only. For professional use only.

Dates and status

Registration Date: Apr 05, 2024

About this record

Access comprehensive regulatory information for Mobile Molecular Diagnostic Workstation in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000536/PCBA-HCM and manufactured by Sansure Biotech Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM.

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.