Taiwan FDA registration 07df0f314a03dedda43228db55cf97a8
Beckman Coulter Chemistry Analyzer (Non-Sterile)
TW: 貝克曼庫爾特全自動生化分析儀 (未滅菌)
Registration details
- Analysis ID
- 07df0f314a03dedda43228db55cf97a8
- Customs Code
- DHA09402330305
Company information
- Manufacturer
- BECKMAN COULTER MISHIMA K.K.
- Manufacturer Country
- Japan
- Authorized Representative
- BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the classification and grading management of medical devices, "Individual photometric chemical analyzer for clinical use (A.2160)" and "Clinical chemical ion analyzer (A.0002)" The first level identification range is limited.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2160 Individual Photometric Chemical Analyzers for Clinical Use;; A.0002 Clinical Chemistry Analyzer
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Nov 10, 2023
- Expiry Date
- Nov 10, 2028
About this record
Access comprehensive regulatory information for Beckman Coulter Chemistry Analyzer (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 07df0f314a03dedda43228db55cf97a8 and manufactured by BECKMAN COULTER MISHIMA K.K.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).
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