Taiwan FDA registration 88332e9fe11a5bfdadd44231069ca8c8

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

TW: "伊名" 新型隱球菌抗原檢測試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·IMMUNO-MYCOLOGICS, INC.·Registered Dec 14, 2017 – Dec 14, 2027Active
Registration details
Analysis ID
88332e9fe11a5bfdadd44231069ca8c8
License Form
Ministry of Health Medical Device Import No. 018605
Customs Code
DHA09401860501
Company information
Manufacturer Country
United States
Authorized Representative
FENG CHI BIOTECH 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
Dec 14, 2017
Expiry Date
Dec 14, 2027
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About this record

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 88332e9fe11a5bfdadd44231069ca8c8 and manufactured by IMMUNO-MYCOLOGICS, INC.. The authorized representative in Taiwan is FENG CHI BIOTECH CORP..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including IMMY, 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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