Taiwan FDA registration 3e5056165f386759797e3a749d67e42a
CJ EZ Drop HbA1c Test
TW: 啟哲易滴糖化血色素體外試劑組
Taiwan·Risk Class 2·MD·Qizhe Biotechnology Co., Ltd·Registered Oct 06, 2017 – Oct 06, 2022ExpiredRegistration details
- Analysis ID
- 3e5056165f386759797e3a749d67e42a
- License Form
- Ministry of Health Medical Device Manufacturing No. 005798
Company information
- Manufacturer
- Qizhe Biotechnology Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Qizhe Biotechnology Co., Ltd
Product details
- Intended Use
- This product is equipped with Qizhe color analyzer (Weibu Medical Instrument No. 007660) to quantitatively detect glycated hemoglobin (HbA1c) in human venous whole blood.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7470 Glycosylated heme analysis
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Oct 06, 2017
- Expiry Date
- Oct 06, 2022
About this record
Access comprehensive regulatory information for CJ EZ Drop HbA1c Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3e5056165f386759797e3a749d67e42a and manufactured by Qizhe Biotechnology Co., Ltd. The authorized representative in Taiwan is Qizhe Biotechnology Co., Ltd.
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