Taiwan FDA registration 48446d9e3514c0c01cc1233133ee7738

Regal Lab Automation System Chemical Cold Light Immunoassay Analyzer (Unsterilized)

TW: "禮雅尚"實驗室自動化系統化學冷光免疫分析儀 (未滅菌)

Taiwan·Risk Class 1·DiaSorin Italia SpA·Registered Oct 01, 2021 – Oct 31, 2025Expired

Registration details

Analysis ID: 48446d9e3514c0c01cc1233133ee7738
Customs Code: DHA08402036401

Company information

Manufacturer: DiaSorin Italia SpA
Manufacturer Country: Italy
Authorized Representative: MEDRICH INSTRUMENT CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the "Individual Photometric Chemistry Analyzer for Clinical Use (A.2160)" 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.2160 Individual Photometric Chemistry Analyzer for Clinical Use
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Oct 01, 2021
Expiry Date: Oct 31, 2025

About this record

Access comprehensive regulatory information for Regal Lab Automation System Chemical Cold Light Immunoassay Analyzer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 48446d9e3514c0c01cc1233133ee7738 and manufactured by DiaSorin Italia SpA. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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