Vietnam MOH registration 240000862/PCBA-HCM

IVD washing in urine and urine sediment analysis

VN: IVD rửa trong xét nghiệm nước tiểu và cặn lắng nước tiểu

Vietnam·Risk Class TTBYT Loại A·EU-20 Diluent·Shenzhen Mindray Bio-Medical Electronics Co., Ltd·Registered Jun 03, 2024

Registration details

Analysis ID: 240000862/PCBA-HCM
Submission ID: 000.00.19.H29-240527-0020
Product Type: EU-20 Diluent

Company information

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Manufacturer Country: CHINA
Product Owner: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Authorized Representative: CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM

Technical details

Intended Use: Used to clean the reaction system in in vitro test for the analyte. The product containing the wash solution is only intended for cleaning equipment and should not be used as a rinse for the reaction system.

Dates and status

Registration Date: Jun 03, 2024

About this record

Access comprehensive regulatory information for IVD washing in urine and urine sediment analysis 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 240000862/PCBA-HCM and manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINDRAY VIỆT NAM.

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