Taiwan FDA registration 2928dc8c8649c9b8ff4b337e02a8ecd0
"SD Biosensor" RSV (Non-sterile)
TW: "艾司迪堡" 呼吸道融合細胞病毒快速檢驗試劑 (未滅菌)
Registration details
- Analysis ID
- 2928dc8c8649c9b8ff4b337e02a8ecd0
- License Form
- Ministry of Health Medical Device Import No. 017775
- Customs Code
- DHA09401777508
Company information
- Manufacturer
- SD BIOSENSOR, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- JOLEX INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Respiratory Fusion Cell Virus Serological Reagent (C.3480)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3480 Respiratory Fusion Cell Virus Serological Reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 28, 2017
- Expiry Date
- Apr 28, 2022
About this record
Access comprehensive regulatory information for "SD Biosensor" RSV (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 2928dc8c8649c9b8ff4b337e02a8ecd0 and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..
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