Vietnam MOH registration 240002431/PCBA-HN

IVD is the automated laboratory testing system

VN: IVD là hệ thống dây chuyền tự động hóa phòng xét nghiệm

Vietnam·Risk Class TBYT Loại A·Power Express (Abbreviated Name on Label: PE)·IDS Co., Ltd.·Registered Oct 31, 2024

Registration details

Analysis ID: 240002431/PCBA-HN
Submission ID: 000.00.19.H26-241029-0013
Product Type: Power Express (Abbreviated Name on Label: PE)

Company information

Manufacturer: IDS Co., Ltd.
Manufacturer Country: JAPAN
Product Owner: Beckman Coulter, Inc.
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: Power Express is a high-speed automated sample processing system that performs the processing of sample tubes from the preparation stage before analysis until the tubes are placed in the sample tray. It can be configured with optional hardware to support the processing of sample tubes on the connected analysis instrument. Power Express performs all the sample preparation work before analysis, directly transferring the sample tubes to the connected analysis instrument for testing. Then, the tubes can be transferred to another connected analysis instrument for further testing and sent to the post-analysis departments.

Dates and status

Registration Date: Oct 31, 2024

About this record

Access comprehensive regulatory information for IVD is the automated laboratory testing system in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại A medical device is registered under number 240002431/PCBA-HN and manufactured by IDS Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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