Taiwan FDA registration eb088428347868481222312a41c08a7a

"Artron" Helicobacter pylori Ag Rapid Test (Non-Sterile)

TW: "亞壯" 幽門桿菌抗原快速檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·MD·ARTRON LABORATORIES INC.·Registered Aug 14, 2015 – Aug 14, 2025Expired

Registration details

Analysis ID: eb088428347868481222312a41c08a7a
License Form: Ministry of Health Medical Device Import No. 015580
Customs Code: DHA09401558009

Company information

Manufacturer: ARTRON LABORATORIES INC.
Manufacturer Country: Canada
Authorized Representative: JOLEX INTERNATIONAL CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C0003 Helicobacter serological reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Aug 14, 2015
Expiry Date: Aug 14, 2025

About this record

Access comprehensive regulatory information for "Artron" Helicobacter pylori Ag Rapid Test (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 eb088428347868481222312a41c08a7a and manufactured by ARTRON LABORATORIES INC.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..

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