Repro-Medical System, Inc., Dba Koru Medical Systems
United StatesFDA applicant, unverified
- Devices
- 2
What Repro-Medical System, Inc., Dba Koru Medical Systems makes
Koru Medical Systems manufactures syringe infusion systems designed for controlled medication delivery, including the FreedomEdge Syringe Infusion System. These devices are intended for use in clinical settings to administer fluids and drugs at precise rates, supporting patient care in infusion therapy.
The company’s products fall under FDA Class II regulation and are authorised via the 510(k) pathway. The devices are listed in the FDA’s 510(k) database. Koru Medical Systems operates from the United States.
Catalogue
FreedomEdge Syringe Infusion System Ref K214045
Regimes: 510(k) Registry: 510(k)FreedomEdge(R) Syringe Infusion System Ref K211206
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Repro-Medical System, Inc., Dba Koru Medical Systems have in the registry?
The registry currently lists 2 devices for Repro-Medical System, Inc., Dba Koru Medical Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Repro-Medical System, Inc., Dba Koru Medical Systems's devices?
Among its 2 most recently registered devices, Repro-Medical System, Inc., Dba Koru Medical Systems has devices listed in FDA 510(k) (2 devices).
What risk classes do Repro-Medical System, Inc., Dba Koru Medical Systems's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Repro-Medical System, Inc., Dba Koru Medical Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Repro-Medical System, Inc., Dba Koru Medical Systems in the registry?
The most recently registered devices listed for Repro-Medical System, Inc., Dba Koru Medical Systems include FreedomEdge Syringe Infusion System and FreedomEdge(R) Syringe Infusion System.