Rocamed Sam
MC Last updated 23 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
What Rocamed Sam makes
Rocamed Sam manufactures ureteral stents, including the JFil Ureteral Stents and the JFil Ureteral Stents ECO Kit, designed for urinary drainage in medical procedures.
These devices fall under FDA Class II regulation and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Rocamed Sam manufacture?
Rocamed Sam specializes in ureteral stents, including the JFil Ureteral Stents and the JFil Ureteral Stents ECO Kit. These devices are specifically designed to facilitate urinary drainage during medical procedures.
Where is Rocamed Sam based?
Rocamed Sam is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US medical device standards.
How are Rocamed Sam’s devices classified by the FDA?
Rocamed Sam’s ureteral stents, such as the JFil Ureteral Stents, are classified as FDA Class II devices. This classification is determined by the risk associated with the device, where Class II devices generally pose moderate risk and require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Rocamed Sam’s devices?
Rocamed Sam’s devices, including the JFil Ureteral Stents and its ECO Kit, are listed in the FDA’s 510(k) registry. This pathway confirms that the devices have undergone the required premarket notification process to demonstrate compliance with applicable regulations before being marketed.
Information
- Country
- MC
- Address
- 9 Avenue Albert II, MONACO Monaco-Ville
- FDA FEI number
- 3016096097