Taiwan FDA registration 7dce1b5e6b0baaf3f4ef01e9d24bece9
"CerTest" Streptococcus pneumoniae(Non-Sterile)
TW: "司爾特" 肺炎鏈球菌尿液抗原快速診斷試劑(未滅菌)
Taiwan·Risk Class 1·MD·CERTEST BIOTEC, S.L.·Registered Mar 29, 2018 – Mar 29, 2028ActiveRegistration details
- Analysis ID
- 7dce1b5e6b0baaf3f4ef01e9d24bece9
- License Form
- Ministry of Health Medical Device Import No. 018937
- Customs Code
- DHA09401893700
Company information
- Manufacturer
- CERTEST BIOTEC, S.L.
- Manufacturer Country
- Spain
- Authorized Representative
- APPLIED BIOTECH ENTERPRISE 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
- Mar 29, 2018
- Expiry Date
- Mar 29, 2028
About this record
Access comprehensive regulatory information for "CerTest" 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 7dce1b5e6b0baaf3f4ef01e9d24bece9 and manufactured by CERTEST BIOTEC, S.L.. The authorized representative in Taiwan is APPLIED BIOTECH ENTERPRISE CO., LTD..
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