Taiwan FDA registration 98f27f730c2977215a038449f4b8099f

"Helena" activates the coagulation time analyzer and activates the coagulation time system

TW: "賀蓮娜"活化凝血時間分析儀及活化凝血時間系統

Taiwan·Risk Class 2·HELENA LABORATORIES, CORP.·Registered Dec 02, 2005 – Dec 02, 2025Expired

Registration details

Analysis ID: 98f27f730c2977215a038449f4b8099f
Customs Code: DHA00601520101

Company information

Manufacturer: HELENA LABORATORIES, CORP.
Manufacturer Country: United States
Authorized Representative: HSIN TUNG MEDICAL CO., LTD.

Product details

Intended Use: The activated whole blood clotting time test measures the clotting time of whole blood to monitor the heparin therapy used in the treatment of venous embolism or pulmonary embolism.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7140 Activated whole blood coagulation time test
Import Information: import

Dates and status

Registration Date: Dec 02, 2005
Expiry Date: Dec 02, 2025

About this record

Access comprehensive regulatory information for "Helena" activates the coagulation time analyzer and activates the coagulation time system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 98f27f730c2977215a038449f4b8099f and manufactured by HELENA LABORATORIES, CORP.. The authorized representative in Taiwan is HSIN TUNG MEDICAL CO., LTD..

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