Taiwan FDA registration 5cd9bdbe61eb0e9c9345a26ea82c8571
"Kipfu" Pneumoniae Nucleic Acid Test Set (Uninacerated)
TW: "基普復" 肺炎黴漿菌核酸檢驗試劑組(未滅菌)
Taiwan·Risk Class 1·GeneProof a. s.·Registered Oct 11, 2023 – Oct 11, 2028ActiveRegistration details
- Analysis ID
- 5cd9bdbe61eb0e9c9345a26ea82c8571
- Customs Code
- DHA09402327207
Company information
- Manufacturer
- GeneProof a. s.
- Manufacturer Country
- Czechia
- Authorized Representative
- MEDTRI CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management method of medical equipment, the first level identification range of "Mycoplasma serum reagent (C.3375)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3375 黴漿菌屬血清試劑
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 11, 2023
- Expiry Date
- Oct 11, 2028
About this record
Access comprehensive regulatory information for "Kipfu" Pneumoniae Nucleic Acid Test Set (Uninacerated) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5cd9bdbe61eb0e9c9345a26ea82c8571 and manufactured by GeneProof a. s.. The authorized representative in Taiwan is MEDTRI CO., LTD..
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