Taiwan FDA registration ddecdca57e551ea9e9d199cad3f45709
Ouxuan Ai urine sediment analysis system
TW: 歐炫艾尿液沉渣分析系統
Taiwan·Risk Class 2·Arkray Factory Inc., Head office factory·Registered Jul 12, 2022 – Jul 12, 2027ActiveRegistration details
- Analysis ID
- ddecdca57e551ea9e9d199cad3f45709
- Customs Code
- DHA05603567502
Company information
- Manufacturer
- Arkray Factory Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- MEDTRI CO., LTD.
Product details
- Intended Use
- This product is an analyzer for performing urine sediment analysis and for calibration, quality control and cleaning fluids on this analyzer.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.5220 Automatic Differential Cell Count
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jul 12, 2022
- Expiry Date
- Jul 12, 2027
About this record
Access comprehensive regulatory information for Ouxuan Ai urine sediment analysis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ddecdca57e551ea9e9d199cad3f45709 and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is MEDTRI CO., LTD..
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