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United China Helicobacter pylori detection system (unsterilized) - Taiwan Registration c9f6b84fb3ce21cb3312c59c4047ab94

Access comprehensive regulatory information for United China Helicobacter pylori detection system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c9f6b84fb3ce21cb3312c59c4047ab94 and manufactured by FIRSTEP BIORESEARCH INC.. The authorized representative in Taiwan is FIRSTEP BIORESEARCH 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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c9f6b84fb3ce21cb3312c59c4047ab94
Registration Details
Taiwan FDA Registration: c9f6b84fb3ce21cb3312c59c4047ab94
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Device Details

United China Helicobacter pylori detection system (unsterilized)
TW: ่ฏ่ฏๅนฝ้–€่žบๆ—‹ๆกฟ่Œๆชขๆธฌ็ณป็ตฑ(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

c9f6b84fb3ce21cb3312c59c4047ab94

Company Information

Taiwan, Province of China

Product Details

It is limited to the first level of identification scope of the "Spirobacter Serum Reagent (C.0003)" and "Colorimeter, Photometer or Spectrophotometer for Clinical Use (A.2300)" in the Classification and Grading Management Measures for Medical Devices.

C Immunology and Microbiology; A Clinical chemistry and clinical toxicology

A.2300 Colorimeter, photometer or spectrophotometer for clinical use; C.0003 Serum reagent for Helicobacter species

QMS/QSD;; ๅœ‹็”ข

Dates and Status

Oct 30, 2018

Oct 30, 2023