Taiwan FDA registration bf6017b59775f034d34d2e1380f3502a

and photovitamin K deficiency induces prothrombin correction solution and quality control solution

TW: 和光維生素K缺乏誘導凝血酶原校正液及品管液
Taiwan flagTaiwan·Risk Class 2·FUJIFILM Wako Pure Chemical Corporation Mie Plant·Registered May 09, 2023 – May 09, 2028Active
Registration details
Analysis ID
bf6017b59775f034d34d2e1380f3502a
Customs Code
DHA05603617602
Company information
Manufacturer Country
Japan
Authorized Representative
MEDICARE PRODUCTS INC.
Product details
Intended Use
Calibration solution: used for the correction of photovitamin K deficiency-induced prothrombin (PIVKA II) test reagent. Quality control solution: quality control for the detection of photovitamin K deficiency-induced prothrombin (PIVKA II).
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1150 calibration;; A.1660 Quality control materials (analytical and non-analytical)
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
May 09, 2023
Expiry Date
May 09, 2028
About this record

Access comprehensive regulatory information for and photovitamin K deficiency induces prothrombin correction solution and quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bf6017b59775f034d34d2e1380f3502a and manufactured by FUJIFILM Wako Pure Chemical Corporation Mie Plant. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..

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