Taiwan FDA registration b39d8b2f7257c52a43cc1684dd134c2d
CH&SEN Urine Ketone Test Strip (Non-sterile)
TW: 昌勝 尿酮檢測試紙 (未滅菌)
Registration details
- Analysis ID
- b39d8b2f7257c52a43cc1684dd134c2d
- Customs Code
- DHA09600482801
Company information
- Manufacturer
- CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.
- Manufacturer Country
- China
- Authorized Representative
- SUNGYIN BIO INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management of medical equipment "Ketone (non-quantitative) test system (A.1435)" first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1435 Ketone (non-quantitative) testing system
- Import Information
- Input;; QMS/QSD;; Chinese goods
Dates and status
- Registration Date
- Sep 21, 2023
- Expiry Date
- Sep 21, 2028
About this record
Access comprehensive regulatory information for CH&SEN Urine Ketone Test Strip (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b39d8b2f7257c52a43cc1684dd134c2d and manufactured by CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.. The authorized representative in Taiwan is SUNGYIN BIO INTERNATIONAL CO., LTD..
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