Taiwan FDA registration c9f6b84fb3ce21cb3312c59c4047ab94

United China Helicobacter pylori detection system (unsterilized)

TW: 聯華幽門螺旋桿菌檢測系統(未滅菌)

Taiwan·Risk Class 1·FIRSTEP BIORESEARCH INC.·Registered Oct 30, 2018 – Oct 30, 2023Expired

Registration details

Analysis ID: c9f6b84fb3ce21cb3312c59c4047ab94

Company information

Manufacturer: FIRSTEP BIORESEARCH INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: FIRSTEP BIORESEARCH INC.

Product details

Intended Use: It is limited to the first level of identification scope of the "Spirobacter Serum Reagent (C.0003)" and "Colorimeter, Photometer or Spectrophotometer for Clinical Use (A.2300)" in the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.2300 Colorimeter, photometer or spectrophotometer for clinical use; C.0003 Serum reagent for Helicobacter species
Import Information: QMS/QSD;; 國產

Dates and status

Registration Date: Oct 30, 2018
Expiry Date: Oct 30, 2023

About this record

Access comprehensive regulatory information for United China Helicobacter pylori detection system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c9f6b84fb3ce21cb3312c59c4047ab94 and manufactured by FIRSTEP BIORESEARCH INC.. The authorized representative in Taiwan is FIRSTEP BIORESEARCH INC..

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