"Helena" Immunodiagnostic Reagent (Non-sterile)
Taiwan·Risk Class 1·MD·HELENA LABORATORIES, INC.·Registered May 17, 2018 – May 17, 2023Expired- Analysis ID
- 516e33f0727fd3ac192578a53513a377
- License Form
- Ministry of Health Medical Device Import No. 019060
- Customs Code
- DHA09401906003
- Manufacturer
- HELENA LABORATORIES, INC.
- Manufacturer Country
- Japan
- 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
- May 17, 2018
- Expiry Date
- May 17, 2023
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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 516e33f0727fd3ac192578a53513a377 and manufactured by HELENA LABORATORIES, INC.. 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 CORP., 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.