Taiwan FDA registration 90d0e14ed196d5d773d8d35b2c7b6c72

"BIOHIT" Helicobacter pylori quick test (Non-Sterile)

TW: "百益"幽門桿菌快速檢驗試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·BIOHIT OYJ·Registered Jan 14, 2015 – Jan 14, 2025Expired
Registration details
Analysis ID
90d0e14ed196d5d773d8d35b2c7b6c72
License Form
Ministry of Health Medical Device Import No. 014849
Customs Code
DHA09401484909
Company information
Manufacturer
BIOHIT OYJ
Manufacturer Country
Finland
Authorized Representative
JOLEX INTERNATIONAL CO., LTD.
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
Jan 14, 2015
Expiry Date
Jan 14, 2025
About this record

Access comprehensive regulatory information for "BIOHIT" Helicobacter pylori quick test (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 90d0e14ed196d5d773d8d35b2c7b6c72 and manufactured by BIOHIT OYJ. The authorized representative in Taiwan is JOLEX INTERNATIONAL 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