Romedex International SRL
Country not established
- Devices
- 2
What Romedex International SRL makes
Romedex International Srl manufactures the EVGUIDE TIP LOCATION SYSTEM, a device used for real-time visualization and precise placement of medical tips, such as catheters or guidewires, during procedures. The company also produces the NAUTILUS DELTA, a system designed for imaging and navigation in interventional radiology and cardiology, aiding in accurate needle or catheter positioning.
The company’s portfolio is regulated under Class II medical devices in the United States, with devices listed via the FDA’s 510(k) pathway. The manufacturer is based in the US.
Catalogue
Evguide Tip Location System Ref K093775
Regimes: 510(k) Registry: 510(k)Nautilus Delta Ref K141634
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Romedex International Srl have in the registry?
The registry currently lists 2 devices for Romedex International Srl. Devices recorded under merged duplicate company entries are counted once.
Which registries list Romedex International Srl's devices?
Among its 2 most recently registered devices, Romedex International Srl has devices listed in FDA 510(k) (2 devices).
What risk classes do Romedex International Srl's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Romedex International Srl's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Romedex International Srl in the registry?
The most recently registered devices listed for Romedex International Srl include EVGUIDE TIP LOCATION SYSTEM and NAUTILUS DELTA.