Taiwan FDA registration f67d583ee3841f0d4dc83a0defb87a9d
Emanutec thyroid peroxidase autoantibody test reagent
TW: 伊曼紐特克甲狀腺過氧化酶自體抗體檢驗試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered May 31, 2022 – May 31, 2027ActiveRegistration details
- Analysis ID
- f67d583ee3841f0d4dc83a0defb87a9d
- Customs Code
- DHAS5603565300
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- This product uses extracorporeal radioimmunoassay to determine the amount of thyroid peroxidase autoantibodies in human serum.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5870 甲狀腺自體抗體免疫試驗系統
- Import Information
- Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); Input;; QMS/QSD
Dates and status
- Registration Date
- May 31, 2022
- Expiry Date
- May 31, 2027
About this record
Access comprehensive regulatory information for Emanutec thyroid peroxidase autoantibody test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f67d583ee3841f0d4dc83a0defb87a9d and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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