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"EKF" Quo-Test A1C measuring system - Taiwan Registration 9a659c9cdc250b679413d2ad23943340

Access comprehensive regulatory information for "EKF" Quo-Test A1C measuring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9a659c9cdc250b679413d2ad23943340 and manufactured by EKF-DIAGNOSTIC GMBH. The authorized representative in Taiwan is AMESDATA BIOTECH CO., LTD..

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9a659c9cdc250b679413d2ad23943340
Registration Details
Taiwan FDA Registration: 9a659c9cdc250b679413d2ad23943340
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Device Details

"EKF" Quo-Test A1C measuring system
TW: "้†ซ็ฆ" ๅปฃๆธฌ้†ฃๅŒ–่ก€่‰ฒ็ด ๅˆ†ๆž็ณป็ตฑ
Risk Class 2
MD

Registration Details

9a659c9cdc250b679413d2ad23943340

Ministry of Health Medical Device Import No. 032179

DHA05603217901

Company Information

Germany

Product Details

This product is used for the quantitative detection of in vitro glycoglycated hemoglobin (HbA1c) obtained from fingerstick blood or intravenous whole blood samples collected in EDTA test tubes.

B Hematology and pathology devices

B7470 Glycosylated heme analysis

Imported from abroad

Dates and Status

Feb 20, 2019

Feb 20, 2024