Taiwan FDA registration 8ef4483a731f060ee2478fd3ae77368d

"Ai Kuailu" B Streptococcus Rapid Test Reagent (Unsterilized)

TW: "艾快露" B群鏈球菌快速檢驗試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ACRO BIOTECH. INC.·Registered Oct 20, 2016 – Oct 20, 2026Active
Registration details
Analysis ID
8ef4483a731f060ee2478fd3ae77368d
Customs Code
DHA09401710209
Company information
Manufacturer
ACRO BIOTECH. INC.
Manufacturer Country
United States
Authorized Representative
Grand Marquis IVD CO., LTD.
Product details
Intended Use
Classification and grading management method of medical equipment: Streptococcus belongs to the first level identification range of serum reagent (C.3740).
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3740 鏈球菌屬血清試劑
Import Information
import
Dates and status
Registration Date
Oct 20, 2016
Expiry Date
Oct 20, 2026
About this record

Access comprehensive regulatory information for "Ai Kuailu" B Streptococcus 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 8ef4483a731f060ee2478fd3ae77368d 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.

Free DatabasePowered by Pure Global AI89,000+ Devices