Taiwan FDA registration bd3cfda2c041165712ac78a1699b5972

"OJET" Automatic Enzyme Immunity Analyzer (Unsterilized)

TW: "歐捷" 全自動酵素免疫分析儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ORGENTEC DIAGNOSTIKA GMBH·Registered Apr 29, 2015 – Apr 29, 2025Cancelled
Registration details
Analysis ID
bd3cfda2c041165712ac78a1699b5972
Customs Code
DHA09401518006
Company information
Manufacturer Country
Germany
Authorized Representative
IN FUNG CO., LTD.
Product details
Intended Use
Limited to the first level identification range of enzyme analyzer for clinical use (A.2500) of the Measures for the Administration of Medical Devices.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2500 Enzyme analyzer for clinical use
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Apr 29, 2015
Expiry Date
Apr 29, 2025
Cancellation Date
Sep 30, 2021
Cancellation information
Status
Logged out
Reason
轉為登錄字號
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About this record

Access comprehensive regulatory information for "OJET" 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 bd3cfda2c041165712ac78a1699b5972 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including ORGENTEC DIAGNOSTIKA GMBH, 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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