Taiwan FDA registration bf656b7ea84789d7a36565fa2616943f

"Aikuailu" Pylori Rapid Test Reagent (Unsterilized)

TW: "艾快露" 幽門桿菌快速檢測試劑 (未滅菌)

Taiwan·Risk Class 1·ACRO BIOTECH INC.·Registered Sep 10, 2016 – Sep 10, 2026Active

Registration details

Analysis ID: bf656b7ea84789d7a36565fa2616943f
Customs Code: DHA09401699504

Company information

Manufacturer: ACRO BIOTECH INC.
Manufacturer Country: United States
Authorized Representative: Grand Marquis IVD CO., LTD.

Product details

Intended Use: Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum reagent (C.0003)".
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.0003 螺旋桿菌屬血清試劑
Import Information: import

Dates and status

Registration Date: Sep 10, 2016
Expiry Date: Sep 10, 2026

About this record

Access comprehensive regulatory information for "Aikuailu" Pylori Rapid Test Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number bf656b7ea84789d7a36565fa2616943f and manufactured by ACRO BIOTECH INC.. The authorized representative in Taiwan is Grand Marquis IVD 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.