IVD Department for Qualitative and Quantitative Analysis of 7 Hemostasis Parameters. - Vietnam Registration 2403454ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department for Qualitative and Quantitative Analysis of 7 Hemostasis Parameters. in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403454ĐKLH/BYT-HTTB and manufactured by Tem Innovations GmbH. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN MEDCOMTECH.
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Device Details
Registration Details
2403454ĐKLH/BYT-HTTB
000.00.04.G18-231221-0058
Theo theo phụ lục
Theo phụ lục
Technical Details
Ex tem: For in vitro diagnostic use only. Ex-tem is a reagent of the ROTEM® system to evaluate the extrinsic coagulation pathway and its interaction with platelets in citrate-anticoagulated blood samples. This product is always used in combination with the star-tem reagent. ROTROL P: For in vitro diagnostic use only. ROTROL P is a quality control material to monitor the accuracy and precision of the tests performed on the ROTEM® system for whole blood coagulation analysis.
Dates and Status
Nov 06, 2024