Sekisui Medical Co., Ltd.
JapanFDA applicant, unverified
- Devices
- 1
What Sekisui Medical Co., Ltd. makes
Sekisui Medical Co., Ltd. manufactures coagulation testing systems, including the CP3000 Coagulation analyzer, along with associated reagents such as Coagpia AT Reagent, Coagpia Calibrator, and Coagpia Control Set. These products are designed for laboratory use to measure blood clotting parameters and ensure accurate diagnostic results.
The company’s coagulation devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States, where Sekisui Medical Co., Ltd. is based.
Catalogue
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set Ref K173202
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sekisui Medical Co., Ltd. have in the registry?
The registry currently lists 1 device for Sekisui Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sekisui Medical Co., Ltd.'s devices?
Among its 1 most recently registered device, Sekisui Medical Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sekisui Medical Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sekisui Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sekisui Medical Co., Ltd. in the registry?
The most recently registered devices listed for Sekisui Medical Co., Ltd. include CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set.