Taiwan FDA registration 949373a6ddff5ae5db8181aab6c5dcca
Emanutec Free Prostate Specific Antigen Radioimmunoassay Set
TW: 伊曼紐特克游離攝護腺特異抗原放射免疫分析試劑組
Taiwan·Risk Class 2·IMMUNOTECH S.R.O·Registered Mar 25, 2021 – Mar 25, 2026ExpiredRegistration details
- Analysis ID
- 949373a6ddff5ae5db8181aab6c5dcca
- Customs Code
- DHA05603437600
Company information
- Manufacturer
- IMMUNOTECH S.R.O
- Manufacturer Country
- Czechia
- Authorized Representative
- MEGA BONA INTERNATIONAL CO., LTD.
Product details
- Intended Use
- This product is used to measure free prostate-specific antigen (PSA) in human serum by external radioimmunoassay.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.6010 腫瘤相關抗原免疫試驗系統
- Import Information
- Input;; QMS/QSD;; 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
- Mar 25, 2021
- Expiry Date
- Mar 25, 2026
About this record
Access comprehensive regulatory information for Emanutec Free Prostate Specific Antigen Radioimmunoassay Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 949373a6ddff5ae5db8181aab6c5dcca and manufactured by IMMUNOTECH S.R.O. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..
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