Taiwan FDA registration 28cc663a96f1e7e0690b6f821cc84f42

"ARKOLAI" glycosylated hemoglobin analysis system

TW: “愛科來”醣化血色素分析系統

Taiwan·Risk Class 2·EKF-DIAGNOSTIC GMBH·Registered Jun 08, 2018 – Jun 08, 2028Active

Registration details

Analysis ID: 28cc663a96f1e7e0690b6f821cc84f42
Customs Code: DHA05603114400

Company information

Manufacturer: EKF-DIAGNOSTIC GMBH
Manufacturer Country: Germany
Authorized Representative: MEDTRI CO., LTD.

Product details

Intended Use: This product is intended to be quantified for in vitro glycoglycated hemoglobin (HbAlc) using whole blood obtained from blood taken from fingertips or from intravenous whole blood samples collected in EDTA test tubes.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); B.7470 Analysis of glycosylated hemoglobin
Import Information: import

Dates and status

Registration Date: Jun 08, 2018
Expiry Date: Jun 08, 2028

About this record

Access comprehensive regulatory information for "ARKOLAI" glycosylated hemoglobin analysis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 28cc663a96f1e7e0690b6f821cc84f42 and manufactured by EKF-DIAGNOSTIC GMBH. The authorized representative in Taiwan is MEDTRI CO., LTD..

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