Taiwan FDA registration 5b2d50ca40e7fdc08d48f58cdcda156b

"Biohit" Helicobacter pylori IgG ELISA KIT(Non-Sterile)

TW: "百得"幽門桿菌IgG酵素免疫分析檢測試劑(未滅菌)

Taiwan·Risk Class 1·MD·BIOHIT OYJ·Registered Apr 18, 2014 – Apr 18, 2024Expired

Registration details

Analysis ID: 5b2d50ca40e7fdc08d48f58cdcda156b
License Form: Ministry of Health Medical Device Import No. 014070
Customs Code: DHA09401407007

Company information

Manufacturer: BIOHIT OYJ
Manufacturer Country: Finland
Authorized Representative: YOULUM BIOTECHNOLOGY 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: Apr 18, 2014
Expiry Date: Apr 18, 2024

About this record

Access comprehensive regulatory information for "Biohit" Helicobacter pylori IgG ELISA KIT(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 5b2d50ca40e7fdc08d48f58cdcda156b and manufactured by BIOHIT OYJ. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..

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