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"Helena" Immunodiagnostic Reagent (Non-sterile) - Taiwan Registration 0788f8af2d3ee27061cb58852368bec7

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 0788f8af2d3ee27061cb58852368bec7 and manufactured by HELENA LABORATORIES CORP.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including HELENA LABORATORIES, 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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0788f8af2d3ee27061cb58852368bec7
Registration Details
Taiwan FDA Registration: 0788f8af2d3ee27061cb58852368bec7
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Device Details

"Helena" Immunodiagnostic Reagent (Non-sterile)
TW: "ๆตทๅ€ซ้‚ฃ" ๅ…็–ซๆชข้ฉ—่ฉฆๅŠ‘ (ๆœชๆป…่Œ)
Risk Class 1
MD

Registration Details

0788f8af2d3ee27061cb58852368bec7

Ministry of Health Medical Device Import No. 018234

DHA09401823405

Company Information

United States

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

Aug 24, 2017

Aug 24, 2027

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