Taiwan FDA registration a7898b3c30069fd7e8c72287814babd3

Dirk Helicobacter pylori antigen enzyme immunoassay reagent (unsterilized)

TW: 德克 幽門螺旋桿菌抗原酵素免疫檢測試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Baoling Fujin Biotechnology Co., Ltd. Xizhi Factory·Registered Dec 01, 2016 – Dec 01, 2021Cancelled
Registration details
Analysis ID
a7898b3c30069fd7e8c72287814babd3
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
Contract manufacturing;; Domestic
Dates and status
Registration Date
Dec 01, 2016
Expiry Date
Dec 01, 2021
Cancellation Date
Sep 08, 2023
Cancellation information
Status
Logged out
Reason
未展延而逾期者
About this record

Access comprehensive regulatory information for Dirk Helicobacter pylori antigen enzyme immunoassay 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 a7898b3c30069fd7e8c72287814babd3 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. 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.

Free DatabasePowered by Pure Global AI89,000+ Devices