Taiwan FDA registration ec3a3a1e420671cb497d0f8715896a3d
Emanutec Free Thyroxine Radioimmunoassay Reagent
TW: 伊曼紐特克游離甲狀腺素放射免疫分析試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered Jun 16, 2023 – Jun 16, 2028ActiveRegistration details
- Analysis ID
- ec3a3a1e420671cb497d0f8715896a3d
- Customs Code
- DHAS5603619103
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- This product is an in vitro diagnostic manual medical device for professionals to quantitatively measure free thyroxine (FT4) in human serum and plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1695 游離甲狀腺素試驗系統
- Import Information
- QMS/QSD;; Input;; Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)
Dates and status
- Registration Date
- Jun 16, 2023
- Expiry Date
- Jun 16, 2028
About this record
Access comprehensive regulatory information for Emanutec Free Thyroxine 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 ec3a3a1e420671cb497d0f8715896a3d and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices