Taiwan FDA registration 57dfd25977cc250d033596d8296a3a4c

"IMMY" Cryptococcal Antigen Lateral Flow Assay (Non-Sterile)

TW: "英名" 新型隱球菌抗原檢測試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·IMMY, Inc.·Registered May 16, 2017 – May 16, 2027Active
Registration details
Analysis ID
57dfd25977cc250d033596d8296a3a4c
License Form
Ministry of Health Medical Device Import No. 017836
Customs Code
DHA09401783602
Company information
Manufacturer
IMMY, Inc.
Manufacturer Country
United States
Authorized Representative
RAFA INTERNATIONAL CORP.
Product details
Intended Use
Limited to the first level of identification range of the Measures for the Administration of Medical Devices "Cryptococcus neoformis serum reagent (C.3165)".
Product Type (Level 1)
C Immunology and microbiology devices
Product Type (Level 2)
C3165 Cryptococcus neoformis serology
Import Information
Imported from abroad
Dates and status
Registration Date
May 16, 2017
Expiry Date
May 16, 2027
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Access comprehensive regulatory information for "IMMY" Cryptococcal Antigen Lateral Flow Assay (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 57dfd25977cc250d033596d8296a3a4c and manufactured by IMMY, Inc.. The authorized representative in Taiwan is RAFA INTERNATIONAL CORP..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including IMMUNO-MYCOLOGICS, INC., and 1 recent registrations in the same category. 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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