Vietnam MOH registration 2403233ĐKLH/BYT-HTTB

IVD Department for Quantitative Blood Glucose Testing

VN: Bộ IVD xét nghiệm định lượng đường huyết

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Roche Diabetes Care GmbH·Registered Nov 02, 2024

Registration details

Analysis ID: 2403233ĐKLH/BYT-HTTB
Submission ID: 17003062/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Roche Diabetes Care GmbH
Manufacturer Country: Theo theo phụ lục
Product Owner: Roche Diabetes Care GmbH
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: Blood Glucose Test: The blood glucose test strip, used in conjunction with a dedicated blood glucose meter, is designed to quantify glucose in the blood of patients with microvascular, venous, arterial blood, and the blood of newborns. It is intended for self-monitoring by patients with diabetes and for use by healthcare professionals to perform point-of-care testing on patients. The dedicated blood glucose meter is the Accu-Chek Active. Patients with diabetes can use blood from the microvascular system, freshly obtained from the tip of a finger, or an alternative blood sampling site. Healthcare professionals can use blood from the venous system, which has been anticoagulated with lithium heparin, ammonium heparin, or EDTA, arterial blood, or blood from newborns. The Accu-Chek Active system is intended for the monitoring of blood glucose in diabetes. The Accu-Chek Active system comprises the Accu-Chek Active meter, the Accu-Chek Active test strip, and the Accu-Chek Active control solution. Control Solution for Quantitative Blood Glucose Testing: This control solution is used to assess the performance of the Accu-Chek Active test strip and the dedicated blood glucose meter. It is intended for self-monitoring by patients with diabetes and for use by healthcare professionals to perform point-of-care testing on patients. The dedicated test strip and device are the Accu-Chek Active test strip and the Accu-Chek Active meter.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for IVD Department for Quantitative Blood Glucose Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403233ĐKLH/BYT-HTTB and manufactured by Roche Diabetes Care GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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