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HelicotecAG H. pylori Antigen Rapid Test Kit (Non-Sterile) - Taiwan Registration 3ad0f3f53628aad563866b1012d23a55

Access comprehensive regulatory information for HelicotecAG H. pylori Antigen Rapid Test 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 3ad0f3f53628aad563866b1012d23a55 and manufactured by STRONG BIOTECH CORP.. The authorized representative in Taiwan is STRONG BIOTECH CORP..

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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3ad0f3f53628aad563866b1012d23a55
Registration Details
Taiwan FDA Registration: 3ad0f3f53628aad563866b1012d23a55
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Device Details

HelicotecAG H. pylori Antigen Rapid Test Kit (Non-Sterile)
TW: "ๅฏฆๅ‰ต" ่ƒƒๅนฝ้–€่žบๆ—‹ๆกฟ่ŒๆŠ—ๅŽŸๅฟซ้€Ÿๆชข้ฉ—่ฉฆๅŠ‘ (ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

3ad0f3f53628aad563866b1012d23a55

Ministry of Health Medical Device Manufacturing No. 007277

Company Information

Taiwan, Province of China

Product Details

Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".

C Immunology and microbiology devices

C0003 Helicobacter serological reagent

Produced in Taiwan, China

Dates and Status

May 29, 2018

May 29, 2028