Taiwan FDA registration 9bfbbaebd6d1b20d46259be814d6f8e4

"Innova" Bayer Flexun Automatic Enzyme Immunity Analyzer (Unsterilized)

TW: "因諾瓦" 拜爾富來迅全自動酵素免疫分析儀(未滅菌)
Taiwan flagTaiwan·Risk Class 1·INOVA DIAGNOSTICS, INC.·Registered Oct 01, 2021 – Oct 31, 2025Expired
Registration details
Analysis ID
9bfbbaebd6d1b20d46259be814d6f8e4
Customs Code
DHA08402073905
Company information
Manufacturer Country
United States
Authorized Representative
TRUGENE DIAGNOSTICS, INC.
Product details
Intended Use
Limited to the classification and grading management measures of medical equipment "Enzyme Analyzer for Clinical Use (A.2500)" first level identification range.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2500 Enzyme analyzer for clinical use
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2025
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About this record

Access comprehensive regulatory information for "Innova" Bayer Flexun Automatic Enzyme Immunity Analyzer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9bfbbaebd6d1b20d46259be814d6f8e4 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including INOVA DIAGNOSTICS, INC., and 1 recent registrations in the same category. 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.

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