Haemoscope Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Haemoscope Corp. makes
Haemoscope Corp. manufactures thromboelastography (TEG) devices, including coagulation analyzers like the TEG 3000S and TEG-5000 Series, as well as the RapidTEG TEG-ACT test and TEG Platelet Mapping Assay. These instruments assess blood clotting dynamics and platelet function to support clinical decision-making in trauma, surgery, and critical care settings.
The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
Thrombelastograph Ref K904204
Regimes: 510(k) Registry: 510(k)Thrombelastograph Coagulation Analyzer 3000S Ref K954437
Regimes: 510(k) Registry: 510(k)Thrombelastograph (Teg) Platelet Mapping Assay Ref K041502
Regimes: 510(k) Registry: 510(k)Thrombelastograph(R) Ref K895844
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Rapidteg Teg-Act Test Ref K062604
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Haemoscope Corp. have in the registry?
The registry currently lists 7 devices for Haemoscope Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haemoscope Corp.'s devices?
Among its 7 most recently registered devices, Haemoscope Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Haemoscope Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Haemoscope Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Haemoscope Corp. in the registry?
The most recently registered devices listed for Haemoscope Corp. include THROMBELASTOGRAPH, THROMBELASTOGRAPH COAGULATION ANALYZER 3000S, THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY and THROMBELASTOGRAPH(R).