Vietnam MOH registration 240001427/PCBA-HN

Mobile Molecular Biology Testing System

VN: Hệ thống xét nghiệm sinh học phân tử di động

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·Sansure Biotech Inc.·Registered Jul 17, 2024

Registration details

Analysis ID: 240001427/PCBA-HN
Submission ID: 000.00.19.H26-240716-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Sansure Biotech Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Sansure Biotech Inc.
Authorized Representative: CÔNG TY TNHH GIẢI PHÁP THIẾT BỊ Y TẾ VIỆT NAM

Technical details

Intended Use: The mobile molecular biology-based diagnostic testing system is used in clinical practice in conjunction with appropriate detection reagents to isolate and qualitatively analyze the target nucleic acid (DNA/RNA) from human samples, including both pathogen and human genetic material samples.

Dates and status

Registration Date: Jul 17, 2024

About this record

Access comprehensive regulatory information for Mobile Molecular Biology Testing System 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 240001427/PCBA-HN and manufactured by Sansure Biotech Inc.. The authorized representative in Vietnam is CÔNG TY TNHH GIẢI PHÁP THIẾT BỊ Y TẾ VIỆT NAM.

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