Taiwan FDA registration f8aaa1373b818cd98968cbe5b0aabad1
LensHooke Sperm Double Strand DNA Fragmentation Test Kit (SDFR assay) (Non-Sterile)
TW: 萊特兒精子去氧核糖核酸雙股斷裂檢測試劑套組(精子去氧核糖核酸碎片擴散染色法) (未滅菌)
Taiwan·Risk Class 1·MD·BONRAYBIO CO., LTD.·Registered Oct 01, 2021 – Oct 31, 2026ActiveRegistration details
- Analysis ID
- f8aaa1373b818cd98968cbe5b0aabad1
- License Form
- Ministry of Health Medical Device Manufacturing Registration No. 008723
Company information
- Manufacturer
- BONRAYBIO CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- BONRAYBIO CO., LTD.
Product details
- Intended Use
- Limited to the first grade identification range of dyes and chemical solution dyes (B.1850) of the management measures for medical devices.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B1850 Dyes and chemical solution dyes
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2026
About this record
Access comprehensive regulatory information for LensHooke Sperm Double Strand DNA Fragmentation Test Kit (SDFR assay) (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 f8aaa1373b818cd98968cbe5b0aabad1 and manufactured by BONRAYBIO CO., LTD.. The authorized representative in Taiwan is BONRAYBIO CO., LTD..
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