Taiwan FDA registration a5a1b7c65a1d5aca13f1b080f2d44ae8
"Abbott" enzyme analyzer (unsterilized)
TW: “亞培”酵素分析儀 (未滅菌)
Registration details
- Analysis ID
- a5a1b7c65a1d5aca13f1b080f2d44ae8
- Customs Code
- DHA08401945109
Company information
- Manufacturer
- TECAN SCHWEIZ AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the classification and grading management measures of medical equipment "Enzyme Analyzer for Clinical Use (A.2500)" first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2500 Enzyme analyzer for clinical use
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2023
- Cancellation Date
- Nov 02, 2023
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Abbott" enzyme analyzer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a5a1b7c65a1d5aca13f1b080f2d44ae8 and manufactured by TECAN SCHWEIZ AG. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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