Taiwan FDA registration 85b7020b0c1c03bf838ec0aa0d95f536

Risby Drug Monitoring Kit - Immunosuppressive drugs

TW: 芮斯比藥物監測套組-免疫抑制藥物

Taiwan·Risk Class 2·RECIPE CHEMICALS + INSTRUMENTS GMBH·Registered Aug 05, 2022 – Aug 05, 2027Active

Registration details

Analysis ID: 85b7020b0c1c03bf838ec0aa0d95f536
Customs Code: DHA05603568900

Company information

Manufacturer: RECIPE CHEMICALS + INSTRUMENTS GMBH
Manufacturer Country: Germany
Authorized Representative: AMEDx International Co., Ltd.

Product details

Intended Use: This system is a universal drug monitoring platform that can be used for liquid chromatography coupled tandem mass spectrometry (LC-MS/MS) to monitor therapeutic drug monitoring TDM, and the Risby Immunosuppressive Drug Add-on Kit can quantitatively detect and monitor the concentrations of Cyclosporin A, tacrolimus, sirolimus and everolimus in human whole blood in a clinically relevant range.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); A.1678 Tacrolimus drug monitoring system;; A.1235 Cyclosporine test system
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 05, 2022
Expiry Date: Aug 05, 2027

About this record

Access comprehensive regulatory information for Risby Drug Monitoring Kit - Immunosuppressive drugs in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 85b7020b0c1c03bf838ec0aa0d95f536 and manufactured by RECIPE CHEMICALS + INSTRUMENTS GMBH. The authorized representative in Taiwan is AMEDx International Co., Ltd..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.