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QUANTA Flash aCL IgM Controls - Taiwan Registration cb47fcb9f692ca46377c4569bdcacb4e

Access comprehensive regulatory information for QUANTA Flash aCL IgM Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cb47fcb9f692ca46377c4569bdcacb4e and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..

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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cb47fcb9f692ca46377c4569bdcacb4e
Registration Details
Taiwan FDA Registration: cb47fcb9f692ca46377c4569bdcacb4e
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Device Details

QUANTA Flash aCL IgM Controls
TW: ๅ› ่ซพ็“ฆๆŠ—ๅฟƒ่„‚่ณชๆŠ—้ซ”ๅ…็–ซ็ƒ่›‹็™ฝMๅŒ–ๅญธๅ†ทๅ…‰ๅ…็–ซๅˆ†ๆžๆณ•ๅฐ็…ง็ต„
Risk Class 2
MD

Registration Details

cb47fcb9f692ca46377c4569bdcacb4e

Ministry of Health Medical Device Import No. 027708

DHA05602770805

Company Information

United States

Product Details

The BIO-FLASH instrument is the quality control of the QUANTA Flash aCL IgM chemiluminescent immunoassay.

A Clinical chemistry and clinical toxicology

A1660 Quality Control Materials (Analytical and Non-Analytical)

Imported from abroad

Dates and Status

Oct 07, 2015

Oct 07, 2025