Taiwan FDA registration 2a1ce4bcebe9b8808b598ef1feff0125

Helicobacter dongyao antigen rapid test reagent (non-sterilized)

TW: 東耀幽門桿菌抗原快速檢驗試劑(未滅菌)

Taiwan·Risk Class 1·TONYAR BIOTECH. INC.·Registered Sep 25, 2024 – Sep 25, 2029Active

Registration details

Analysis ID: 2a1ce4bcebe9b8808b598ef1feff0125

Company information

Manufacturer: TONYAR BIOTECH. INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: TONYAR BIOTECH. INC.

Product details

Intended Use: It is limited to the first-level identification scope of the "Helicobacter Serum Reagent (C.0003)" of the Classification and Grading Management Measures for Medical Devices.
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: 國產;; QMS/QSD

Dates and status

Registration Date: Sep 25, 2024
Expiry Date: Sep 25, 2029

About this record

Access comprehensive regulatory information for Helicobacter dongyao antigen rapid test reagent (non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2a1ce4bcebe9b8808b598ef1feff0125 and manufactured by TONYAR BIOTECH. INC.. The authorized representative in Taiwan is TONYAR BIOTECH. INC..

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