Taiwan FDA registration 512fa7f14e5cf89a9589156a366e0ce8
SDB STANDARD F Analyzer (Non-sterile)
TW: 愛斯德畢 快速螢光分析儀 (未滅菌)
Registration details
- Analysis ID
- 512fa7f14e5cf89a9589156a366e0ce8
- License Form
- Ministry of Health Medical Device Import Registration No. a00027
- Customs Code
- DHA084a0002704
Company information
- Manufacturer
- SD BIOSENSOR, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- LINKSEAS TRADING CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management measures of medical equipment "fluorescence instrument for clinical use (A.2560)" the first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A2560 fluorometer for clinical use
Dates and status
- Registration Date
- Dec 14, 2021
- Expiry Date
- Oct 31, 2023
About this record
Access comprehensive regulatory information for SDB STANDARD F Analyzer (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 512fa7f14e5cf89a9589156a366e0ce8 and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is LINKSEAS TRADING CO., LTD..
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