Taiwan FDA registration 23ca3759aa6fbe09f0d0400cf99745b8
KETOSURE POC Ketone Control Solution (Non-Sterile)
TW: 欣舒測專業型血酮品管液(未滅菌)
Taiwan·Risk Class 1·MD·APEX BIOTECHNOLOGY CORPORATION·Registered Oct 14, 2020 – Oct 14, 2025ExpiredRegistration details
- Analysis ID
- 23ca3759aa6fbe09f0d0400cf99745b8
- License Form
- Ministry of Health Medical Device Manufacturing No. 008631
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 quality control materials (analytical and non-analytical) (A.1660) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Oct 14, 2020
- Expiry Date
- Oct 14, 2025
About this record
Access comprehensive regulatory information for KETOSURE POC Ketone Control Solution (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 23ca3759aa6fbe09f0d0400cf99745b8 and manufactured by APEX BIOTECHNOLOGY CORPORATION. The authorized representative in Taiwan is APEX BIOTECHNOLOGY CORPORATION.
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.
Free DatabasePowered by Pure Global AI89,000+ Devices