Taiwan FDA registration a5268d5509268cc457947c7c5cbe0e68
SD BIOSENSOR STANDARD F Influenza A/B FIA (Non-Sterile)
TW: “速得百森”流行性感冒病毒快速檢測血清試劑(未滅菌)
Registration details
- Analysis ID
- a5268d5509268cc457947c7c5cbe0e68
- License Form
- Ministry of Health Medical Device Import No. 020125
- Customs Code
- DHA09402012505
Company information
- Manufacturer
- SD BIOSENSOR,INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Qixin Biotechnology Co., Ltd
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Influenza Virus Serum Reagent (C.3330)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3330 Influenza virus serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 26, 2019
- Expiry Date
- Feb 26, 2024
About this record
Access comprehensive regulatory information for SD BIOSENSOR STANDARD F Influenza A/B FIA (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 a5268d5509268cc457947c7c5cbe0e68 and manufactured by SD BIOSENSOR,INC.. The authorized representative in Taiwan is Qixin Biotechnology 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