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"Helena" QuickGel Lipoprotein kit (Non-sterile) - Taiwan Registration 9b146df56e30af93cab772b30878b8b7

Access comprehensive regulatory information for "Helena" QuickGel Lipoprotein 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 9b146df56e30af93cab772b30878b8b7 and manufactured by HELENA LABORATORIES, INC.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..

This page provides complete technical specifications, regulatory compliance details. 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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9b146df56e30af93cab772b30878b8b7
Registration Details
Taiwan FDA Registration: 9b146df56e30af93cab772b30878b8b7
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Device Details

"Helena" QuickGel Lipoprotein kit (Non-sterile)
TW: "ๆตทๅ€ซ้‚ฃ" ่„‚่›‹็™ฝ่ฉฆๅŠ‘็ต„ (ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

9b146df56e30af93cab772b30878b8b7

Ministry of Health Medical Device Import No. 016917

DHA09401691700

Company Information

Japan

Product Details

Limited to the first level recognition range of the lipoprotein test system (A.1475) of the medical device management method.

A Clinical chemistry and clinical toxicology

A1475 Lipoprotein Testing System

Imported from abroad

Dates and Status

Aug 23, 2016

Aug 23, 2021