Taiwan FDA registration f4db12410fb0a90d8a4d16b7c6a937de

"Helena" capillary electrophoresis analyzer (unsterilized)

TW: "海倫那" 毛細電泳分析儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·HELENA LABORATORIES CORP.·Registered Oct 01, 2021 – Oct 31, 2026Active
Registration details
Analysis ID
f4db12410fb0a90d8a4d16b7c6a937de
Customs Code
DHA08401039506
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 "Electrophoresis Equipment for Clinical Use (A.2485)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2485 Electrophoresis equipment for clinical use
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2026
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About this record

Access comprehensive regulatory information for "Helena" capillary electrophoresis 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 f4db12410fb0a90d8a4d16b7c6a937de 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 CORP., 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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