Taiwan FDA registration 18cb4fe2086733eb42993710c64e9980
"Trinity" Mycoplasma Pneumoniae Test (non-sterile)
TW: "萃尼諦" 肺炎黴漿菌檢測試劑 (未滅菌)
Registration details
- Analysis ID
- 18cb4fe2086733eb42993710c64e9980
- License Form
- Ministry of Health Medical Device Import No. 021217
- Customs Code
- DHA09402121702
Company information
- Manufacturer
- TRINITY BIOTECH USA
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Mycoplasma Serological Reagent (C.3375)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3375 Mycoplasma serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jan 31, 2020
- Expiry Date
- Jan 31, 2025
About this record
Access comprehensive regulatory information for "Trinity" Mycoplasma Pneumoniae Test (non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 18cb4fe2086733eb42993710c64e9980 and manufactured by TRINITY BIOTECH USA. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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