Taiwan FDA registration 3aa02f36b0229f085f29300d99989cee

Roche Cobas automatic blood coagulation analyzer series

TW: 羅氏可霸斯全自動血液凝固分析儀系列

Taiwan·Risk Class 2·Roche Diagnostics International Ltd;; ROCHE DIAGNOSTICS GMBH·Registered Dec 28, 2018 – Dec 28, 2028Active

Registration details

Analysis ID: 3aa02f36b0229f085f29300d99989cee
Customs Code: DHA05603199408

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 fully automated, random can be continuously put on the machine, software-controlled system, used for coagulation, color and immunoturbidimetry analysis, used in a variety of coagulation tests, in vitro qualitative and quantitative coagulation determination, the results are used to assist the diagnosis of coagulation abnormalities and the monitoring of anticoagulant therapy. This product is a system for the determination of coagulation analytes using human citric acid plasma.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.5425 Versatile system for in vitro agglutination studies
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Dec 28, 2018
Expiry Date: Dec 28, 2028

About this record

Access comprehensive regulatory information for Roche Cobas automatic blood coagulation analyzer series in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3aa02f36b0229f085f29300d99989cee and manufactured by Roche Diagnostics International Ltd;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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