"Helena" Immunodiagnostic Reagent (Non-sterile)
Taiwan·Risk Class 1·MD·HELENA LABORATORIES CORP.·Registered Aug 24, 2017 – Aug 24, 2027Active- Analysis ID
- 0788f8af2d3ee27061cb58852368bec7
- License Form
- Ministry of Health Medical Device Import No. 018234
- Customs Code
- DHA09401823405
- Manufacturer
- HELENA LABORATORIES CORP.
- Manufacturer Country
- United States
- Authorized Representative
- SHANG LI INSTRUMENTS CO., LTD.
- Intended Use
- 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)".
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5700 Human whole plasma or serum immunoassay system
- Import Information
- Imported from abroad
- Registration Date
- Aug 24, 2017
- Expiry Date
- Aug 24, 2027
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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.