Taiwan FDA registration 16f22479be7a020604ff1e6e72ae2de4
“Abbott” Insulin Reagent Kit (Non-Sterile)
TW: “亞培”胰島素檢驗試劑組(未滅菌)
Taiwan·Risk Class 1·MD·DENKA SEIKEN CO., LTD.·Registered Jan 08, 2019 – Jan 08, 2024ExpiredRegistration details
- Analysis ID
- 16f22479be7a020604ff1e6e72ae2de4
- License Form
- Ministry of Health Medical Device Import No. 020000
- Customs Code
- DHA09402000001
Company information
- Manufacturer
- DENKA SEIKEN CO., LTD.
- Manufacturer Country
- Japan
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the first level identification range of the immunoresponsive insulin test system (A.1405) of the management method for medical devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1405 Immunoresponsive Insulin Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jan 08, 2019
- Expiry Date
- Jan 08, 2024
About this record
Access comprehensive regulatory information for “Abbott” Insulin Reagent Kit (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 16f22479be7a020604ff1e6e72ae2de4 and manufactured by DENKA SEIKEN CO., LTD.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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