Taiwan FDA registration c3a8438025a1c96273d627a4ca1ab05c
"Apper" insulin test set (unsterilized)
TW: "亞培" 胰島素檢驗試劑組(未滅菌)
Taiwan·Risk Class 1·DENKA CO., LTD·Registered Jun 25, 2021 – Jun 25, 2026ExpiredRegistration details
- Analysis ID
- c3a8438025a1c96273d627a4ca1ab05c
- Customs Code
- DHA09402257507
Company information
- Manufacturer
- DENKA CO., LTD
- Manufacturer Country
- Japan
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the classification and grading management method of medical equipment, immuno-reactive insulin test system (A.1405) first level recognition range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1405 Immune Response Insulin Test System
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jun 25, 2021
- Expiry Date
- Jun 25, 2026
About this record
Access comprehensive regulatory information for "Apper" insulin test set (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c3a8438025a1c96273d627a4ca1ab05c and manufactured by DENKA CO., LTD. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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