Taiwan FDA registration bd4079a7bdc9deb4931c33fe5b969103
"AGRA" fully automatic glycated hemoglobin system
TW: “愛科來” 全自動糖化血色素系統
Taiwan·Risk Class 2·ARKRAY Factory, Inc., Head office factory·Registered Oct 24, 2016 – Oct 24, 2026ActiveRegistration details
- Analysis ID
- bd4079a7bdc9deb4931c33fe5b969103
- Customs Code
- DHA05602893100
Company information
- Manufacturer
- ARKRAY Factory, Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- MEDTRI CO., LTD.
Product details
- Intended Use
- This product is used to measure HbA1c glycoglobin to provide the necessary information for blood sugar control in diabetics. It measures values such as HbA1c (S-A1c, HbA1c) and HbF.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 calibration;; B.7470 Analysis of glycosylated hemoglobin
- Import Information
- import
Dates and status
- Registration Date
- Oct 24, 2016
- Expiry Date
- Oct 24, 2026
About this record
Access comprehensive regulatory information for "AGRA" fully automatic glycated hemoglobin system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bd4079a7bdc9deb4931c33fe5b969103 and manufactured by ARKRAY Factory, Inc., Head office factory. The authorized representative in Taiwan is MEDTRI CO., LTD..
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