Taiwan FDA registration 6fab89b54350486ddb86f0c18522fa2d

"Radiometer" blood gas analysis system reagent kit

TW: “雷度” 血液氣體分析系統試劑包

Taiwan·Risk Class 2·Radiometer Medical ApS;; Radiometer Solutions Sp. z o.o.·Registered Oct 05, 2020 – Oct 05, 2025Expired

Registration details

Analysis ID: 6fab89b54350486ddb86f0c18522fa2d
Customs Code: DHA05603368301

Company information

Manufacturer: Radiometer Medical ApS;; Radiometer Solutions Sp. z o.o.
Manufacturer Country: Poland;;Denmark
Authorized Representative: MEDTRUST INTERNATIONAL CO., LTD.

Product details

Intended Use: This product is suitable for the ABL90 FLEX analyzer calibration sensor, quality control, accuracy and precision evaluation, measurement system flushing, and waste collection from the analyzer.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Oct 05, 2020
Expiry Date: Oct 05, 2025

About this record

Access comprehensive regulatory information for "Radiometer" blood gas analysis system reagent kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6fab89b54350486ddb86f0c18522fa2d and manufactured by Radiometer Medical ApS;; Radiometer Solutions Sp. z o.o.. The authorized representative in Taiwan is MEDTRUST INTERNATIONAL CO., LTD..

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