Taiwan FDA registration f81d06b4a79e461deff602ed61b72028

Roche Cobas Automated Immunoassay Analyzer (Unsterilized)

TW: 羅氏可霸斯全自動免疫分析儀 (未滅菌)

Taiwan·Risk Class 1·ROCHE DIAGNOSTICS GMBH;; HITACHI HIGH-TECH CORPORATION, NAKA DIVISION·Registered Apr 27, 2023 – Apr 27, 2028Active

Registration details

Analysis ID: f81d06b4a79e461deff602ed61b72028
Customs Code: DHA09402310208

Company information

Manufacturer: ROCHE DIAGNOSTICS GMBH;; HITACHI HIGH-TECH CORPORATION, NAKA DIVISION
Manufacturer Country: Germany;;Japan
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: Limited to the classification and grading management of medical devices, "Individual photometric chemical analyzer for clinical use (A.2160)" and "Clinical chemical ion analyzer (A.0002)" The first level identification range is limited.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.2160 Individual Photometric Chemical Analyzers for Clinical Use;; A.0002 Clinical Chemistry Analyzer
Import Information: QMS/QSD;; 委託製造;; 輸入

Dates and status

Registration Date: Apr 27, 2023
Expiry Date: Apr 27, 2028

About this record

Access comprehensive regulatory information for Roche Cobas Automated Immunoassay Analyzer (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f81d06b4a79e461deff602ed61b72028 and manufactured by ROCHE DIAGNOSTICS GMBH;; HITACHI HIGH-TECH CORPORATION, NAKA DIVISION. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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