Taiwan FDA registration 74c185abe86f65c978716ced4518b020

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·Baoling Fujin Biotechnology Co., Ltd. Xizhi Factory·Registered Dec 06, 2016 – Dec 06, 2021Cancelled
Registration details
Analysis ID
74c185abe86f65c978716ced4518b020
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
Dec 06, 2016
Expiry Date
Dec 06, 2021
Cancellation Date
Sep 08, 2023
Cancellation information
Status
Logged out
Reason
未展延而逾期者
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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 74c185abe86f65c978716ced4518b020 and manufactured by Baoling Fujin Biotechnology Co., Ltd. Xizhi Factory. 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 TONYAR BIOTECH. INC., 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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