Taiwan FDA registration 926672b36bfe8bc5133c68633856e9ed

Emanutec insulin precursor C-Shengxi reagent

TW: 伊曼紐特克胰島素前質C-胜呔試劑
Taiwan flagTaiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Sep 21, 2022 – Sep 21, 2027Active
Registration details
Analysis ID
926672b36bfe8bc5133c68633856e9ed
Customs Code
DHAS5603585407
Company information
Manufacturer
IMMUNOTECH S.R.O.
Manufacturer Country
Czechia
Authorized Representative
MEGA BONA INTERNATIONAL CO., LTD.
Product details
Intended Use
This product is used by extracorporeal radiation immunoassay to determine the insulin precursor C-Shengxin in human serum and plasma.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1135 胰島素前質C-肽類試驗系統
Import Information
Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); QMS/QSD;; input
Dates and status
Registration Date
Sep 21, 2022
Expiry Date
Sep 21, 2027
About this record

Access comprehensive regulatory information for Emanutec insulin precursor C-Shengxi reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 926672b36bfe8bc5133c68633856e9ed and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..

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