Taiwan FDA registration c5498203cbfa1c024c65f3379f34d636

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

TW: "愛可羅"幽門桿菌檢驗試劑(未滅菌)

Taiwan·Risk Class 1·MD·ACRO BIOTECH. INC.·Registered Jan 24, 2018 – Jan 24, 2028Active

Registration details

Analysis ID: c5498203cbfa1c024c65f3379f34d636
License Form: Ministry of Health Medical Device Import No. 018754
Customs Code: DHA09401875405

Company information

Manufacturer: ACRO BIOTECH. INC.
Manufacturer Country: United States
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 24, 2018
Expiry Date: Jan 24, 2028

About this record

Access comprehensive regulatory information for "ACRO" 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 c5498203cbfa1c024c65f3379f34d636 and manufactured by ACRO BIOTECH. INC.. The authorized representative in Taiwan is APPLIED BIOTECH ENTERPRISE CO., LTD..

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