Vietnam MOH registration 240000318/PCBA-HN

Automated Cell Suspension Sample Preparation System

VN: Hệ thống chuẩn bị mẫu tế bào nhúng dịch tự động

Vietnam·Risk Class TTBYT Loại A·Theo theo phụ lục·Bionit Inc.·Registered Mar 08, 2024

Registration details

Analysis ID: 240000318/PCBA-HN
Submission ID: 000.00.19.H26-240229-0012
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Bionit Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Bionit Inc.
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: The WellPrep Hely6 Processor System consists of the WellPrep Hely6 Processor and disposable materials used to automatically process smears of embedded cells through centrifugation, separation, and application of the required cells onto glass slides. The prepared slides are then used for the diagnosis of abnormal cells, precancerous cells, and cancer cells.

Dates and status

Registration Date: Mar 08, 2024

About this record

Access comprehensive regulatory information for Automated Cell Suspension Sample Preparation 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 240000318/PCBA-HN and manufactured by Bionit Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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