Vietnam MOH registration 2403454ĐKLH/BYT-HTTB

IVD Department for Qualitative and Quantitative Analysis of 7 Hemostasis Parameters.

VN: Bộ IVD xét nghiệm định tính và định lượng 7 thông số đông máu.

Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Tem Innovations GmbH·Registered Nov 06, 2024

Registration details

Analysis ID: 2403454ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231221-0058
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Tem Innovations GmbH
Manufacturer Country: Theo theo phụ lục
Product Owner: Tem Innovations GmbH
Authorized Representative: CÔNG TY CỔ PHẦN MEDCOMTECH

Technical details

Intended Use: 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

Registration Date: Nov 06, 2024

About this record

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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