Taiwan FDA registration fe48a08debf290f9c16a362f80f3b581
"Arkra" blood glucose test solution (unsterilized)
TW: "愛科來" 血糖測試品管液 (未滅菌)
Taiwan·Risk Class 1·Arkray Factory Inc., Head office factory·Registered Dec 08, 2015 – Dec 08, 2020CancelledRegistration details
- Analysis ID
- fe48a08debf290f9c16a362f80f3b581
- Customs Code
- DHA09401595105
Company information
- Manufacturer
- Arkray Factory Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of quality control materials (analytical and non-analytical) (A.1660) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 08, 2015
- Expiry Date
- Dec 08, 2020
- Cancellation Date
- Jul 15, 2022
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Arkra" blood glucose test solution (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number fe48a08debf290f9c16a362f80f3b581 and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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