Taiwan FDA registration 5dd4640dc83cb6d84e01fa047a070849
Emanutec testosterone radioimmunoassay reagent
TW: 伊曼紐特克睪固酮放射免疫分析試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Jul 01, 2022 – Jul 01, 2027ActiveRegistration details
- Analysis ID
- 5dd4640dc83cb6d84e01fa047a070849
- Customs Code
- DHAS5603566902
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Determination of testosterone in human serum and plasma by external beam immunoassay.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1680 Testosterone test system
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); Input;; QMS/QSD
Dates and status
- Registration Date
- Jul 01, 2022
- Expiry Date
- Jul 01, 2027
About this record
Access comprehensive regulatory information for Emanutec testosterone 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 5dd4640dc83cb6d84e01fa047a070849 and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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