Taiwan FDA registration ae3a8a8990ec644238fd99c6757450dc

Roche Cobas C 111 Biochemistry Analyzer (incl. Ion Selective Electrode Module)

TW: 羅氏可霸斯 c 111生化分析儀 (含離子選擇電極模組)

Taiwan·Risk Class 2·Roche Diagnostics International Ltd;; ROCHE DIAGNOSTICS GMBH·Registered Jul 25, 2016 – Jul 25, 2026Expired

Registration details

Analysis ID: ae3a8a8990ec644238fd99c6757450dc
Customs Code: DHA05602846204

Company information

Manufacturer: Roche Diagnostics International Ltd;; ROCHE DIAGNOSTICS GMBH
Manufacturer Country: Germany;;Switzerland
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product is used to determine clinical chemical and electrolyte parameters in serum, plasma, urine or whole blood (HbAlc) in vitro.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1170 Chloride test system;; A.2150 Continuous Flow Multi-Factor Chemistry Analyzer for Clinical Use; A.1665 Sodium Test System
Import Information: Contract manufacturing;; input

Dates and status

Registration Date: Jul 25, 2016
Expiry Date: Jul 25, 2026

About this record

Access comprehensive regulatory information for Roche Cobas C 111 Biochemistry Analyzer (incl. Ion Selective Electrode Module) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ae3a8a8990ec644238fd99c6757450dc and manufactured by Roche Diagnostics International Ltd;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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