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"Heliana" lipoprotein reagent set (unsterilized) - Taiwan Registration 64fb0ed75579e88bcc3a7a5db8d07eb4

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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64fb0ed75579e88bcc3a7a5db8d07eb4
Registration Details
Taiwan FDA Registration: 64fb0ed75579e88bcc3a7a5db8d07eb4
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Device Details

"Heliana" lipoprotein reagent set (unsterilized)
TW: โ€œ่ณ€่“ฎ้‚ฃโ€ ่„‚่›‹็™ฝ่ฉฆๅŠ‘็ต„(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

64fb0ed75579e88bcc3a7a5db8d07eb4

DHA09402267103

Company Information

United States

Product Details

Limited to the classification and grading management method of medical equipment, lipoprotein test system (A.1475) first level recognition range.

A Clinical chemistry and clinical toxicology

A.1475 Lipoprotein Testing System

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Sep 30, 2021

Sep 30, 2026

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