Taiwan FDA registration e751e80b4741db34ca4a433be19759f4
“EKF”Quo-Lab A1C measuring system
TW: “醫福”廣實驗醣化血色素分析系統
Taiwan·Risk Class 2·MD·EKF-diagnostic GmbH·Registered Apr 23, 2019 – Apr 23, 2024ExpiredRegistration details
- Analysis ID
- e751e80b4741db34ca4a433be19759f4
- License Form
- Ministry of Health Medical Device Import No. 032413
- Customs Code
- DHA05603241306
Company information
- Manufacturer
- EKF-diagnostic GmbH
- Manufacturer Country
- Germany
- Authorized Representative
- AMESDATA BIOTECH CO., LTD.
Product details
- Intended Use
- This product is used for the quantitative detection of in vitro glycohydrated hemoglobin (HbA1C) obtained from fingertip blood or intravenous whole blood samples collected in EDTA test tubes.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7470 Glycosylated heme analysis
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 23, 2019
- Expiry Date
- Apr 23, 2024
About this record
Access comprehensive regulatory information for “EKF”Quo-Lab 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 e751e80b4741db34ca4a433be19759f4 and manufactured by EKF-diagnostic GmbH. The authorized representative in Taiwan is AMESDATA BIOTECH CO., LTD..
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