Taiwan FDA registration e0949e12c8a3682404f3344ce1dd0b4d
SEBIA CAPI 3 HbAlc Kit
TW: 賽比亞 第三代毛細管糖化血色素檢測套組
Taiwan·Risk Class 2·MD·SEBIA·Registered Apr 28, 2016 – Apr 28, 2026ExpiredRegistration details
- Analysis ID
- e0949e12c8a3682404f3344ce1dd0b4d
- License Form
- Ministry of Health Medical Device Import No. 028414
- Customs Code
- DHA05602841406
Company information
- Manufacturer
- SEBIA
- Manufacturer Country
- France
- Authorized Representative
- ARQon Medtech Co., Ltd.
Product details
- Intended Use
- This product is used with a fully automatic capillary electrophoresis instrument (CAPILLARYS 3) in alkaline buffer (pH 9.4) to isolate and quantify glycated hemoglobin Alc (HbAlc) in human blood.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B7470 Glycosylated heme analysis
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 28, 2016
- Expiry Date
- Apr 28, 2026
About this record
Access comprehensive regulatory information for SEBIA CAPI 3 HbAlc Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e0949e12c8a3682404f3344ce1dd0b4d and manufactured by SEBIA. The authorized representative in Taiwan is ARQon Medtech Co., Ltd..
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