Taiwan FDA registration 5ba52c0cc5436b272e82eb02358b7268
"BioMérieux" mass spectrometer for clinical use (unsterilized)
TW: "生物梅里埃" 臨床使用的質譜儀 (未滅菌)
Registration details
- Analysis ID
- 5ba52c0cc5436b272e82eb02358b7268
- Customs Code
- DHA09402293001
Company information
- Manufacturer
- BIOMERIEUX S.A.;; KMC SYSTEMS, INC.
- Manufacturer Country
- France;;United States
- Authorized Representative
- BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
Product details
- Intended Use
- Limited to the classification and grading management method of medical equipment "mass spectrometer for clinical use (A.2860)" the first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2860 Mass spectrometer for clinical use
- Import Information
- 委託製造;; QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 20, 2022
- Expiry Date
- Oct 20, 2027
About this record
Access comprehensive regulatory information for "BioMérieux" mass spectrometer for clinical use (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5ba52c0cc5436b272e82eb02358b7268 and manufactured by BIOMERIEUX S.A.;; KMC SYSTEMS, INC.. The authorized representative in Taiwan is BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG).
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