Taiwan FDA registration b7165cf31fd52c45aa56014afc77f7b8

Osiotius Reader

TW: 奧素歐緹司判讀機

Taiwan·Risk Class 2·Mack Molding Company;; ORTHO CLINICAL DIAGNOSTICS·Registered Feb 14, 2022 – Feb 14, 2027Active

Registration details

Analysis ID: b7165cf31fd52c45aa56014afc77f7b8
Customs Code: DHA05603522000

Company information

Manufacturer: Mack Molding Company;; ORTHO CLINICAL DIAGNOSTICS
Manufacturer Country: United Kingdom;;United States
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: This product is designed for the automatic interpretation of response valence, report results and data management using Osabai Column Agglutination Card technology for human blood in vitro immunohematology tests.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.9175 Automated Blood Classification and Antibody Testing System
Import Information: QMS/QSD;; 輸入;; 委託製造

Dates and status

Registration Date: Feb 14, 2022
Expiry Date: Feb 14, 2027

About this record

Access comprehensive regulatory information for Osiotius Reader in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b7165cf31fd52c45aa56014afc77f7b8 and manufactured by Mack Molding Company;; ORTHO CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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