Taiwan FDA registration b39d8b2f7257c52a43cc1684dd134c2d

CH&SEN Urine Ketone Test Strip (Non-sterile)

TW: 昌勝 尿酮檢測試紙 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.·Registered Sep 21, 2023 – Sep 21, 2028Active
Registration details
Analysis ID
b39d8b2f7257c52a43cc1684dd134c2d
Customs Code
DHA09600482801
Company information
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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