Taiwan FDA registration 0297f96329082a78d511e2241a28c599

"Formosa BioMedicine" Xunzhi Gastric Helicobacter pylori antigen rapid test reagent (unsterilized)

TW: "台塑生醫" 迅知胃幽門螺旋桿菌抗原快速檢驗試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered May 09, 2014 – May 09, 2029Active
Registration details
Analysis ID
0297f96329082a78d511e2241a28c599
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum 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
QMS/QSD;; 國產
Dates and status
Registration Date
May 09, 2014
Expiry Date
May 09, 2029
About this record

Access comprehensive regulatory information for "Formosa BioMedicine" Xunzhi Gastric 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 0297f96329082a78d511e2241a28c599 and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION.

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