Taiwan FDA registration 17424735f162779933014c5f70d252e7
Roche Cobas blood glucose test strips
TW: 羅氏可霸斯血糖試紙
Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH·Registered Aug 25, 2023 – Aug 25, 2028ActiveRegistration details
- Analysis ID
- 17424735f162779933014c5f70d252e7
- Customs Code
- DHA05603621601
Company information
- Manufacturer
- ROCHE DIAGNOSTICS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product provides an in vitro diagnostic test for the quantitative measurement of glucose in venous whole blood, arterial whole blood, microvascular whole blood, neonatal heel blood, and neonatal arterial whole blood samples on the Cobas Pulse System.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1345 Glucose Test System
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 25, 2023
- Expiry Date
- Aug 25, 2028
About this record
Access comprehensive regulatory information for Roche Cobas blood glucose test strips in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 17424735f162779933014c5f70d252e7 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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