Taiwan FDA registration 02ff5b1e1b58c525c660f1a42aca2847

Roche Echo Multifunctional Metabolic Detection System (Non-Sterile)

TW: 羅氏愛可全多功能代謝檢測系統(未滅菌)

Taiwan·Risk Class 1·ROCHE DIAGNOSTICS GMBH·Registered Sep 27, 2023 – Sep 27, 2028Active

Registration details

Analysis ID: 02ff5b1e1b58c525c660f1a42aca2847
Customs Code: DHA09402325902

Company information

Manufacturer: ROCHE DIAGNOSTICS GMBH
Manufacturer Country: Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: It is limited to the first-level identification scope of the "Cholesterol (Total) Test System (A.1175)" and "Triglyceride Test System (A.1705)" of the Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1705 Triglyceride test system;; A.1175 Cholesterol (Total) Testing System
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Sep 27, 2023
Expiry Date: Sep 27, 2028

About this record

Access comprehensive regulatory information for Roche Echo Multifunctional Metabolic Detection System (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 02ff5b1e1b58c525c660f1a42aca2847 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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