Taiwan FDA registration 88ef686b668529b0915a4eec62d6e33a
IL ACL TOP Coagulation Analyzer-50 Series
TW: 實驗儀器公司頂極凝集器械分析儀-五十系列
Registration details
- Analysis ID
- 88ef686b668529b0915a4eec62d6e33a
- License Form
- Ministry of Health Medical Device Import No. 029321
- Customs Code
- DHA05602932104
Company information
- Manufacturer
- INSTRUMENTATION LABORATORY CO.
- Manufacturer Country
- United States
- Authorized Representative
- Werfen Taiwan Limited
Product details
- Intended Use
- This product is an automated analyzer for in vitro diagnostic coagulation laboratory and/or fibrinolytic system monitoring, clinical testing in thrombosis and/or hemostasis laboratories, and can provide direct coagulation test results and calculation results.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B5400 agglutination instrument
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 07, 2017
- Expiry Date
- Feb 07, 2027
About this record
Access comprehensive regulatory information for IL ACL TOP Coagulation Analyzer-50 Series in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 88ef686b668529b0915a4eec62d6e33a and manufactured by INSTRUMENTATION LABORATORY CO.. The authorized representative in Taiwan is Werfen Taiwan Limited.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
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