Taiwan FDA registration fa68a55e8887f586665dc4e4a91100db

"Helena" Immunodiagnostic System (Non-Sterile)

TW: "海倫那" 免疫試驗系統 (未滅菌)

Taiwan·Risk Class 1·MD·HELENA LABORATORIES CORP.·Registered Jun 07, 2017 – Jun 07, 2022Expired

Registration details

Analysis ID: fa68a55e8887f586665dc4e4a91100db
License Form: Ministry of Health Medical Device Import No. 017933
Customs Code: DHA09401793300

Company information

Manufacturer: HELENA LABORATORIES CORP.
Manufacturer Country: United States
Authorized Representative: SHANG LI INSTRUMENTS CO., LTD.

Product details

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

Dates and status

Registration Date: Jun 07, 2017
Expiry Date: Jun 07, 2022

About this record

Access comprehensive regulatory information for "Helena" Immunodiagnostic System (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 fa68a55e8887f586665dc4e4a91100db and manufactured by HELENA LABORATORIES CORP.. The authorized representative in Taiwan is SHANG LI INSTRUMENTS CO., LTD..

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