Taiwan FDA registration 8256127fd87d7cf7581b76416ef896be

"Rapigen" H. pylori Test (Non-Sterile)

TW: "瑞健" 幽門桿菌檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·MD·RAPIGEN INC.·Registered Jan 10, 2017 – Jan 10, 2022Expired

Registration details

Analysis ID: 8256127fd87d7cf7581b76416ef896be
License Form: Ministry of Health Medical Device Import No. 017393
Customs Code: DHA09401739307

Company information

Manufacturer: RAPIGEN INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: APPLIED BIOTECH ENTERPRISE 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 10, 2017
Expiry Date: Jan 10, 2022

About this record

Access comprehensive regulatory information for "Rapigen" H. pylori 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 8256127fd87d7cf7581b76416ef896be and manufactured by RAPIGEN INC.. The authorized representative in Taiwan is APPLIED BIOTECH ENTERPRISE CO., LTD..

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