Taiwan FDA registration 8a559f0a16da52aa0717136afdb2faa3

"ichroma" Helicobacter Pylori Antigen Rapid Test (Non-Sterile)

TW: "艾濶瑪"幽門螺旋桿菌抗原檢測試劑(未滅菌)

Taiwan·Risk Class 1·MD·Boditech Med Inc.·Registered Mar 30, 2021 – Mar 30, 2026Expired

Registration details

Analysis ID: 8a559f0a16da52aa0717136afdb2faa3
License Form: Ministry of Health Medical Device Import No. 022427
Customs Code: DHA09402242705

Company information

Manufacturer: Boditech Med Inc.
Manufacturer Country: Korea, Republic of
Authorized Representative: MEDRICH INSTRUMENT 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: Mar 30, 2021
Expiry Date: Mar 30, 2026

About this record

Access comprehensive regulatory information for "ichroma" Helicobacter Pylori Antigen Rapid 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 8a559f0a16da52aa0717136afdb2faa3 and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..

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