"Helena" Immunodiagnostic Reagent (Non-sterile) - Taiwan Registration 516e33f0727fd3ac192578a53513a377
Access comprehensive regulatory information for "Helena" Immunodiagnostic Reagent (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 516e33f0727fd3ac192578a53513a377 and manufactured by HELENA LABORATORIES, INC.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..
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Device Details
Registration Details
516e33f0727fd3ac192578a53513a377
Ministry of Health Medical Device Import No. 019060
DHA09401906003
Product Details
Limited to the first level identification range of the Measures for the Administration of Medical Devices "Human Whole Plasma or Serum Immunoassay System (C.5700)".
C Immunology and microbiology devices
C5700 Human whole plasma or serum immunoassay system
Imported from abroad
Dates and Status
May 17, 2018
May 17, 2023