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Helicobacter dongyao antigen rapid test reagent (non-sterilized) - Taiwan Registration 2a1ce4bcebe9b8808b598ef1feff0125

Access comprehensive regulatory information for Helicobacter dongyao antigen rapid test reagent (non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2a1ce4bcebe9b8808b598ef1feff0125 and manufactured by TONYAR BIOTECH. INC.. The authorized representative in Taiwan is TONYAR BIOTECH. 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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2a1ce4bcebe9b8808b598ef1feff0125
Registration Details
Taiwan FDA Registration: 2a1ce4bcebe9b8808b598ef1feff0125
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Device Details

Helicobacter dongyao antigen rapid test reagent (non-sterilized)
TW: ๆฑ่€€ๅนฝ้–€ๆกฟ่ŒๆŠ—ๅŽŸๅฟซ้€Ÿๆชข้ฉ—่ฉฆๅŠ‘(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

2a1ce4bcebe9b8808b598ef1feff0125

Company Information

Taiwan, Province of China

Product Details

It is limited to the first-level identification scope of the "Helicobacter Serum Reagent (C.0003)" of the Classification and Grading Management Measures for Medical Devices.

C Immunology and microbiology

C.0003 ่žบๆ—‹ๆกฟ่Œๅฑฌ่ก€ๆธ…่ฉฆๅŠ‘

ๅœ‹็”ข;; QMS/QSD

Dates and Status

Sep 25, 2024

Sep 25, 2029