Taiwan FDA registration 40ce10255bef96a95c5d23468963d8ea
"SD Biosensor" Streptococcus Pneumoniae (Non-sterile)
TW: "艾司迪堡" 肺炎鏈球菌尿液抗原快速診斷試劑 (未滅菌)
Taiwan·Risk Class 1·MD·SD BIOSENSOR, INC.·Registered Apr 28, 2017 – Apr 28, 2022ExpiredRegistration details
- Analysis ID
- 40ce10255bef96a95c5d23468963d8ea
- License Form
- Ministry of Health Medical Device Import No. 017776
- Customs Code
- DHA09401777600
Company information
- Manufacturer
- SD BIOSENSOR, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- JOLEX INTERNATIONAL CO., LTD.
Product details
- Intended Use
- Restriction of medical device management methods Streptococcus belongs to the first level identification range of serum reagent (C.3740).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3740 Streptococcus serology
- 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" Streptococcus Pneumoniae (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 40ce10255bef96a95c5d23468963d8ea and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is JOLEX INTERNATIONAL CO., LTD..
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