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Roche Cobas Automated Immunoassay Analyzer (Unsterilized) - Taiwan Registration f81d06b4a79e461deff602ed61b72028

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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f81d06b4a79e461deff602ed61b72028
Registration Details
Taiwan FDA Registration: f81d06b4a79e461deff602ed61b72028
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Device Details

Roche Cobas Automated Immunoassay Analyzer (Unsterilized)
TW: ็พ…ๆฐๅฏ้œธๆ–ฏๅ…จ่‡ชๅ‹•ๅ…็–ซๅˆ†ๆžๅ„€ (ๆœชๆป…่Œ)
Risk Class 1

Registration Details

f81d06b4a79e461deff602ed61b72028

DHA09402310208

Company Information

Product Details

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.

A Clinical chemistry and clinical toxicology

A.2160 Individual Photometric Chemical Analyzers for Clinical Use;; A.0002 Clinical Chemistry Analyzer

QMS/QSD;; ๅง”่จ—่ฃฝ้€ ;; ่ผธๅ…ฅ

Dates and Status

Apr 27, 2023

Apr 27, 2028