Coramed Technologies, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Coramed Technologies, LLC makes
Coramed Technologies, LLC manufactures the CORA System, an in vitro diagnostic device for coagulation analysis, and its variant with a Platelet Mapping Assay for additional platelet function testing. These systems are designed to assess blood clotting parameters and platelet reactivity in laboratory settings.
The CORA System and its Platelet Mapping Assay variant are classified as Class II devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
CORA (Coagulation Resonance Analysis) System Ref K150041
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Coramed Technologies, LLC have in the registry?
The registry currently lists 2 devices for Coramed Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coramed Technologies, LLC's devices?
Among its 2 most recently registered devices, Coramed Technologies, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Coramed Technologies, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Coramed Technologies, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Coramed Technologies, LLC in the registry?
The most recently registered devices listed for Coramed Technologies, LLC include CORA (Coagulation Resonance Analysis) System and CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY.