Taiwan FDA registration ddf8f7b66db9789907df322e042e788c

Helicobacter dongyao antibody rapid test reagent (non-sterilized)

TW: 東耀幽門桿菌抗體快速檢驗試劑(未滅菌)

Taiwan·Risk Class 1·TONYAR BIOTECH. INC.·Registered May 27, 2024 – May 27, 2029Active

Registration details

Analysis ID: ddf8f7b66db9789907df322e042e788c

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: May 27, 2024
Expiry Date: May 27, 2029

About this record

Access comprehensive regulatory information for Helicobacter dongyao antibody 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 ddf8f7b66db9789907df322e042e788c and manufactured by TONYAR BIOTECH. INC.. The authorized representative in Taiwan is TONYAR BIOTECH. INC..

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.