Taiwan FDA registration 6c7dd8980596bb9e74a90ed5d8b827ed
Kebia procoagulation enzyme time reagent
TW: 克比亞前凝血酵素時間試劑
Taiwan·Risk Class 2·SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT·Registered May 20, 2013 – May 20, 2018CancelledRegistration details
- Analysis ID
- 6c7dd8980596bb9e74a90ed5d8b827ed
- Customs Code
- DHA00602469300
Company information
- Manufacturer
- SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
- Manufacturer Country
- Japan
- Authorized Representative
- KUO'S YUAN IN ENTERPRISE CO., LTD.
Product details
- Intended Use
- The clotting time of the plasma is measured. It is mainly used for the auxiliary diagnosis of various diseases caused by abnormal coagulation function in the external pathway, or as a monitoring of oral anticoagulant therapy.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; B.7750 Blood Clot Time Trial
- Import Information
- import
Dates and status
- Registration Date
- May 20, 2013
- Expiry Date
- May 20, 2018
- Cancellation Date
- Nov 04, 2019
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for Kebia procoagulation enzyme time reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6c7dd8980596bb9e74a90ed5d8b827ed and manufactured by SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..
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