Taiwan FDA registration c55b90a9a37e520aa538bf4a6a2d3c91
“Biohit” PepsinogenⅡ
TW: “百得” 胃蛋白酶原Ⅱ酵素免疫檢測試劑
Taiwan·Risk Class 2·MD·BIOHIT OYJ·Registered Nov 27, 2015 – Nov 27, 2025ExpiredRegistration details
- Analysis ID
- c55b90a9a37e520aa538bf4a6a2d3c91
- License Form
- Ministry of Health Medical Device Import No. 027918
- Customs Code
- DHA05602791803
Company information
- Manufacturer
- BIOHIT OYJ
- Manufacturer Country
- Finland
- Authorized Representative
- YOULUM BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- This product is used by enzyme-linked immunosorbent assay (ELISA) technology for the quantitative detection of PGII. in human plasma or serum for in vitro diagnostics.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 27, 2015
- Expiry Date
- Nov 27, 2025
About this record
Access comprehensive regulatory information for “Biohit” PepsinogenⅡ in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c55b90a9a37e520aa538bf4a6a2d3c91 and manufactured by BIOHIT OYJ. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..
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