Taiwan FDA registration b2ecf2cdafffe6bdb78234b896ea9805

ImmunoCAP Phadiatop

TW: 英尤凱吸入性過敏原篩檢試劑
Taiwan flagTaiwan·Risk Class 2·MD·PHADIA AB·Registered Nov 17, 2015 – Nov 17, 2025Expired
Registration details
Analysis ID
b2ecf2cdafffe6bdb78234b896ea9805
License Form
Ministry of Health Medical Device Import No. 027906
Customs Code
DHA05602790609
Company information
Manufacturer
PHADIA AB
Manufacturer Country
Sweden
Authorized Representative
PHADIA TAIWAN INC.
Product details
Intended Use
This product qualitatively and semi-quantitatively grades the specific IgE of inhaled allergens in human serum or plasma. Its purpose is for clinical laboratory in vitro diagnosis, combined with other clinical evidence as an auxiliary clinical diagnosis method for IgE allergic diseases. This product is used with Fadia 100, Fadia 250 or Fadia 1000 instruments for testing.
Product Type (Level 1)
C Immunology and microbiology devices
Product Type (Level 2)
C5510 Immunoglobulins A, G, M, D and E Immunoassay System
Import Information
Imported from abroad
Dates and status
Registration Date
Nov 17, 2015
Expiry Date
Nov 17, 2025
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About this record

Access comprehensive regulatory information for ImmunoCAP Phadiatop in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b2ecf2cdafffe6bdb78234b896ea9805 and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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