Taiwan FDA registration fe11481d49e0031d995061910e79b9da

“Helena” CSF Protein reagent kit (Non-sterile)

TW: “海倫那”腦脊髓液蛋白試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·HELENA LABORATORIES CORP.·Registered Feb 13, 2019 – Feb 13, 2029Active
Registration details
Analysis ID
fe11481d49e0031d995061910e79b9da
License Form
Ministry of Health Medical Device Import No. 020093
Customs Code
DHA09402009305
Company information
Manufacturer Country
United States
Authorized Representative
SHANG LI INSTRUMENTS CO., LTD.
Product details
Intended Use
Limited to the first level identification range of the Measures for the Administration of Medical Devices "Protein (Chemical Separation Method) Test System (A.1630)".
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A1630 Protein (Chemical Separation) Test System
Import Information
Imported from abroad
Dates and status
Registration Date
Feb 13, 2019
Expiry Date
Feb 13, 2029
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About this record

Access comprehensive regulatory information for “Helena” CSF Protein reagent kit (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number fe11481d49e0031d995061910e79b9da and manufactured by HELENA LABORATORIES CORP.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including HELENA LABORATORIES 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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