Taiwan FDA registration 0b91343062e74859d72f8c1a4c75d818
Beckman Coulter Cortisol radioimmunoassay reagent
TW: 貝克曼庫爾特皮質醇放射免疫分析試劑
Registration details
- Analysis ID
- 0b91343062e74859d72f8c1a4c75d818
- Customs Code
- DHAS5602955307
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- This product utilizes radioimmunoassay to quantify cortisol in human plasma, serum and urine in vitro.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1205 皮質醇(氫基腎上腺素,及羥皮質固醇)試驗系統;; A.1660 品管材料(分析與非分析);; A.1150 校正品
- Import Information
- 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
- Apr 21, 2017
- Expiry Date
- Apr 21, 2027
About this record
Access comprehensive regulatory information for Beckman Coulter Cortisol 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 0b91343062e74859d72f8c1a4c75d818 and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).
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