Taiwan FDA registration 0bc2d0bbc413c7d522956ca58f1015a8
〝BECKMAN COULTER〞UniCel DxC 860i Synchron Access Clinical System Instrument (Non-sterile)
TW: 〝貝克曼庫爾特〞自動生化免疫分析儀 (未滅菌)
Taiwan·Risk Class 1·MD·BECKMAN COULTER, INC.·Registered Oct 01, 2021 – Oct 31, 2027ActiveRegistration details
- Analysis ID
- 0bc2d0bbc413c7d522956ca58f1015a8
- License Form
- Ministry of Health Medical Device Import Registration No. 011155
- Customs Code
- DHA08401115504
Company information
- Manufacturer
- BECKMAN COULTER, INC.
- Manufacturer Country
- United States
- Authorized Representative
- BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the first level identification range of the "Individual Photometric Chemical Analyzer for Clinical Use (A.2160)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A2160 Individual photometric chemistry analyzer for clinical use
- Import Information
- Imported from abroad; GMP
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2027
About this record
Access comprehensive regulatory information for 〝BECKMAN COULTER〞UniCel DxC 860i Synchron Access Clinical System Instrument (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 0bc2d0bbc413c7d522956ca58f1015a8 and manufactured by BECKMAN COULTER, INC.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).
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