Taiwan FDA registration 2ea42cab5a0c78ccdeb6dd634ca549c3
Recording of Paz G high-sensitivity cardiac troponin-I assay
TW: 錄秘帕斯G高靈敏度心肌肌鈣蛋白-I檢驗試劑
Taiwan·Risk Class 2·FUJIREBIO INC. SAGAMIHARA FACILITY.·Registered Jul 01, 2019 – Jul 01, 2029ActiveRegistration details
- Analysis ID
- 2ea42cab5a0c78ccdeb6dd634ca549c3
- Customs Code
- DHA05603245601
Company information
- Manufacturer
- FUJIREBIO INC. SAGAMIHARA FACILITY.
- Manufacturer Country
- Japan
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- This product is used with Lumipulse G1200 for the quantitative determination of cardiac troponin (Triponin I) in human serum or plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 calibration;; A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
- Import Information
- import
Dates and status
- Registration Date
- Jul 01, 2019
- Expiry Date
- Jul 01, 2029
About this record
Access comprehensive regulatory information for Recording of Paz G high-sensitivity cardiac troponin-I assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2ea42cab5a0c78ccdeb6dd634ca549c3 and manufactured by FUJIREBIO INC. SAGAMIHARA FACILITY.. The authorized representative in Taiwan is Grand Marquis IVD 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