Taiwan FDA registration 3c86eb2c1d648f6685003091be7cdf02
KETOSURE POC Blood Ketone Monitoring System (Non-Sterile)
TW: 欣舒測專業型血酮測試系統(未滅菌)
Taiwan·Risk Class 1·MD·APEX BIOTECHNOLOGY CORPORATION·Registered Aug 14, 2020 – Aug 14, 2025ExpiredRegistration details
- Analysis ID
- 3c86eb2c1d648f6685003091be7cdf02
- License Form
- Ministry of Health Medical Device Manufacturing No. 008520
- Customs Code
- DHY09300852009
Company information
- Manufacturer
- APEX BIOTECHNOLOGY CORPORATION
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- APEX BIOTECHNOLOGY CORPORATION
Product details
- Intended Use
- Limited to the first level identification range of the "Ketone (Non-quantitative) Test System (A.1435)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1435 Ketone (non-quantitative) test system
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Aug 14, 2020
- Expiry Date
- Aug 14, 2025
About this record
Access comprehensive regulatory information for KETOSURE POC Blood Ketone Monitoring System (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 3c86eb2c1d648f6685003091be7cdf02 and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.
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