Taiwan FDA registration 4b9ad924652716b36239310a06e208ee

Dirk Gastro Helicobacter pylori antigen rapid test reagent (unsterilized)

TW: 德克 胃幽門螺旋桿菌抗原快速檢驗試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·TONYAR BIOTECH. INC.·Registered Jun 19, 2018 – Jun 19, 2023Expired
Registration details
Analysis ID
4b9ad924652716b36239310a06e208ee
Company information
Manufacturer Country
Taiwan, Province of China
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
Product Type (Level 2)
C.0003 螺旋桿菌屬血清試劑
Import Information
Domestic;; Contract manufacturing
Dates and status
Registration Date
Jun 19, 2018
Expiry Date
Jun 19, 2023
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About this record

Access comprehensive regulatory information for Dirk Gastro Helicobacter pylori antigen rapid test reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 4b9ad924652716b36239310a06e208ee and manufactured by TONYAR BIOTECH. INC.. The authorized representative in Taiwan is REININGHUN DIAGNOSTICS BIOMEDICAL CORPORATION.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Baoling Fujin Biotechnology Co., Ltd. Xizhi Factory, and 1 recent registrations in the same category. 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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