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"ACRO BIOTECH" Strep A Rapid Test (Non-Sterile) - Taiwan Registration 11ca03427bae4b6e2f740ddbd0c5afd8

Access comprehensive regulatory information for "ACRO BIOTECH" Strep A 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 11ca03427bae4b6e2f740ddbd0c5afd8 and manufactured by ACRO BIOTECH INC.. The authorized representative in Taiwan is APPLIED BIOTECH ENTERPRISE 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.

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11ca03427bae4b6e2f740ddbd0c5afd8
Registration Details
Taiwan FDA Registration: 11ca03427bae4b6e2f740ddbd0c5afd8
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Device Details

"ACRO BIOTECH" Strep A Rapid Test (Non-Sterile)
TW: "ๆ„›ๅฏ็พ…" Aๅž‹้ˆ็ƒ่Œ่ฉฆๅŠ‘(ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

11ca03427bae4b6e2f740ddbd0c5afd8

Ministry of Health Medical Device Import No. 021251

DHA09402125102

Company Information

United States

Product Details

Restriction of medical device management methods Streptococcus belongs to the first level identification range of serum reagent (C.3740).

C Immunology and microbiology devices

C3740 Streptococcus serology

Imported from abroad

Dates and Status

Feb 12, 2020

Feb 12, 2025