Taiwan FDA registration 84155fb43ba932e2b3a391dee0b361d1

Roche Cobas Ion Selector (Non-Sterile)

TW: 羅氏可霸斯離子選擇分析儀 (未滅菌)

Taiwan·Risk Class 1·ROCHE DIABETES CARE GMBH;; Hitachi High-Technologies Corporation Naka Division·Registered Oct 21, 2024 – Oct 21, 2029Active

Registration details

Analysis ID: 84155fb43ba932e2b3a391dee0b361d1
Customs Code: DHA09402363504

Company information

Manufacturer: ROCHE DIABETES CARE GMBH;; Hitachi High-Technologies Corporation Naka Division
Manufacturer Country: Germany;;Japan
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: It is limited to the first-level identification scope of the "Clinical Chemical Ion Analyzer (A.0002)" Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.0002 Clinicalized Molecule Analyzer
Import Information: 委託製造;; 輸入;; QMS/QSD

Dates and status

Registration Date: Oct 21, 2024
Expiry Date: Oct 21, 2029

About this record

Access comprehensive regulatory information for Roche Cobas Ion Selector (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 84155fb43ba932e2b3a391dee0b361d1 and manufactured by ROCHE DIABETES CARE GMBH;; Hitachi High-Technologies Corporation Naka Division. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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