Taiwan FDA registration 631b88c6c5a2c170ea284494ef4d8013
Emanutec insulin radioimmunoassay reagent
TW: 伊曼紐特克胰島素放射免疫分析試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Oct 18, 2022 – Oct 18, 2027ActiveRegistration details
- Analysis ID
- 631b88c6c5a2c170ea284494ef4d8013
- Customs Code
- DHAS5603586308
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Immunoassay of external beam radiation is used to determine insulin in human serum and plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1405 Immune Response Insulin Test System
- Import Information
- QMS/QSD;; Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); input
Dates and status
- Registration Date
- Oct 18, 2022
- Expiry Date
- Oct 18, 2027
About this record
Access comprehensive regulatory information for Emanutec insulin radioimmunoassay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 631b88c6c5a2c170ea284494ef4d8013 and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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