Taiwan FDA registration f42bd218c9e82c7f835eb77aa8603ef0

"Helena" electrophoresis analyzer (unsterilized)

TW: "海倫那" 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
f42bd218c9e82c7f835eb77aa8603ef0
Customs Code
DHA08401039608
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
Input;; QMS/QSD
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" 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 f42bd218c9e82c7f835eb77aa8603ef0 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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