Taiwan FDA registration 08653865edb324d78b4956357551faea

BECKMAN COULTER Access Immunoassay Sytstem (Non-Sterile)

TW: 貝克曼庫爾特亞瑟斯免疫分析系統(未滅菌)

Taiwan·Risk Class 1·MD·BECKMAN COULTER INC.·Registered Oct 01, 2021 – Oct 31, 2025Expired

Registration details

Analysis ID: 08653865edb324d78b4956357551faea
License Form: Ministry of Health Medical Device Import Registration No. 001050
Customs Code: DHA08400105000

Company information

Manufacturer: BECKMAN COULTER INC.
Manufacturer Country: United States
Authorized Representative: BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: Arthurs Immunoassay System provides automated quantitative analysis of serum immunology in vitro diagnosis performed by clinical laboratories, and Arthurs Immunoassay System provides routine serum immunology examination items including hormonal test, thyroid test, anemia test, cardiac examination, infection source test and cancer test.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A2160 Individual photometric chemistry analyzer for clinical use
Import Information: Imported from abroad

Dates and status

Registration Date: Oct 01, 2021
Expiry Date: Oct 31, 2025

About this record

Access comprehensive regulatory information for BECKMAN COULTER Access Immunoassay Sytstem (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 08653865edb324d78b4956357551faea and manufactured by BECKMAN COULTER INC.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

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