Taiwan FDA registration 017e1a8306ee389bc9561fa9d4580e66
"Mingjie" Helicobacter pylori test reagent (serum/plasma) (unsterilized)
TW: "明傑" 幽門螺旋桿菌測試試劑 (血清/血漿) (未滅菌)
Registration details
- Analysis ID
- 017e1a8306ee389bc9561fa9d4580e66
- Customs Code
- DHA09600353300
Company information
- Manufacturer
- Zhejiang Orient Gene Biotech Co.,LTD
- Manufacturer Country
- China
- Authorized Representative
- MIN JIER FIRM
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
- Input;; Chinese goods
Dates and status
- Registration Date
- Aug 24, 2018
- Expiry Date
- Aug 24, 2023
About this record
Access comprehensive regulatory information for "Mingjie" Helicobacter pylori test reagent (serum/plasma) (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 017e1a8306ee389bc9561fa9d4580e66 and manufactured by Zhejiang Orient Gene Biotech Co.,LTD. The authorized representative in Taiwan is MIN JIER FIRM.
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