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Sign in to claim this brandRenata Medical, Inc.
US
Last updated May 31, 2026
What Renata Medical, Inc. makes
Renata Medical, Inc. manufactures bare-metal aortic stents, including the Minima Stent System in sizes 6mm, 8mm, and an unspecified variant. These devices are designed for vascular interventions within the aorta.
The company’s products fall under FDA Class III regulation and are listed under the Premarket Approval (PMA) and Unique Device Identification (UDI) programs. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Renata Medical, Inc. manufacture?
Renata Medical, Inc. specializes in bare-metal aortic stents, specifically the Minima Stent System. These devices are engineered for use in vascular procedures within the aorta, helping to treat conditions like aneurysms or stenosis by providing structural support to the vessel walls.
Where is Renata Medical, Inc. based?
Renata Medical, Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance, as it operates under U.S. medical device regulations.
How are Renata Medical, Inc.’s devices classified by regulatory authorities?
Renata Medical, Inc.’s devices, including the Minima Stent System, are classified as Class III by the FDA. This classification applies to high-risk medical devices that require rigorous pre-market approval due to their potential impact on patient safety and health outcomes.
Which regulatory registries or databases list Renata Medical, Inc.’s devices?
Renata Medical, Inc.’s devices are listed under the FDA’s Premarket Approval (PMA) program, which requires comprehensive clinical data to demonstrate safety and effectiveness. Additionally, they are included in the FDA’s Unique Device Identification (UDI) system, ensuring traceability and transparency in the supply chain.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 084169964
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Minima Stent System - 8mm | FG-0002 | FDA UDI | Class III | Active |
| Minima Stent System - 6mm | FG-0001 | FDA UDI | Class III | Active |
| Minima Stent System | P240003 | FDA PMA | Class III | Active |
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