Taiwan FDA registration 64fb0ed75579e88bcc3a7a5db8d07eb4

"Heliana" lipoprotein reagent set (unsterilized)

TW: “賀蓮那” 脂蛋白試劑組(未滅菌)
Taiwan flagTaiwan·Risk Class 1·HELENA LABORATORIES, CORP.·Registered Sep 30, 2021 – Sep 30, 2026Active
Registration details
Analysis ID
64fb0ed75579e88bcc3a7a5db8d07eb4
Customs Code
DHA09402267103
Company information
Manufacturer Country
United States
Authorized Representative
SHANG LI INSTRUMENTS CO., LTD.
Product details
Intended Use
Limited to the classification and grading management method of medical equipment, lipoprotein test system (A.1475) first level recognition range.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1475 Lipoprotein Testing System
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Sep 30, 2021
Expiry Date
Sep 30, 2026
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About this record

Access comprehensive regulatory information for "Heliana" lipoprotein reagent set (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 64fb0ed75579e88bcc3a7a5db8d07eb4 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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