Taiwan FDA registration 6489faab93e6e3604321b48e59667e91
“CERTEST”H. Pylori Ag (Non-Sterile)
TW: “微栩”幽門桿菌抗原檢驗試劑(未滅菌)
Registration details
- Analysis ID
- 6489faab93e6e3604321b48e59667e91
- License Form
- Ministry of Health Medical Device Import No. 021616
- Customs Code
- DHA09402161603
Company information
- Manufacturer
- CERTEST BIOTEC S.L.
- Manufacturer Country
- Spain
- Authorized Representative
- WISH IN COMPANY LIMITED
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C0003 Helicobacter serological reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 05, 2020
- Expiry Date
- Jun 05, 2025
About this record
Access comprehensive regulatory information for “CERTEST”H. Pylori Ag (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 6489faab93e6e3604321b48e59667e91 and manufactured by CERTEST BIOTEC S.L.. The authorized representative in Taiwan is WISH IN COMPANY LIMITED.
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