Taiwan FDA registration 9a659c9cdc250b679413d2ad23943340
"EKF" Quo-Test A1C measuring system
TW: "醫福" 廣測醣化血色素分析系統
Taiwan·Risk Class 2·MD·EKF-DIAGNOSTIC GMBH·Registered Feb 20, 2019 – Feb 20, 2024ExpiredRegistration details
- Analysis ID
- 9a659c9cdc250b679413d2ad23943340
- License Form
- Ministry of Health Medical Device Import No. 032179
- Customs Code
- DHA05603217901
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 glycoglycated hemoglobin (HbA1c) obtained from fingerstick 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
- Feb 20, 2019
- Expiry Date
- Feb 20, 2024
About this record
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..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices