Taiwan FDA registration 109b9f057199060e612186056225de9c
Speed Test New blood glucose monitoring system
TW: 耐速測 全新 血糖監測系統
Taiwan·Risk Class 2·BIOPTIK TECHNOLOGY, INC.·Registered Jul 20, 2018 – Jul 20, 2028ActiveRegistration details
- Analysis ID
- 109b9f057199060e612186056225de9c
Company information
- Manufacturer
- BIOPTIK TECHNOLOGY, INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- KERNEL INT'L CORP.
Product details
- Intended Use
- This product is for in vitro testing only, measuring blood glucose levels with fresh fingertip microvascular whole blood. This product can be used by self-testing and professionals, but is not intended for testing of newborns.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Jul 20, 2018
- Expiry Date
- Jul 20, 2028
About this record
Access comprehensive regulatory information for Speed Test New blood glucose monitoring system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 109b9f057199060e612186056225de9c and manufactured by BIOPTIK TECHNOLOGY, INC.. The authorized representative in Taiwan is KERNEL INT'L CORP..
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