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)
Taiwan flagTaiwan·Risk Class 1·BIOMERIEUX S.A.;; KMC SYSTEMS, INC.·Registered Oct 20, 2022 – Oct 20, 2027Active
Registration details
Analysis ID
5ba52c0cc5436b272e82eb02358b7268
Customs Code
DHA09402293001
Company information
Manufacturer Country
France;;United States
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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