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Sign in to claim this brandWhat COROVENTIS Research AB makes
CoroVentis Research AB manufactures software systems designed for cardiac catheterization laboratories, including the CoroFlow platform and its associated upgrade kits. These tools are intended to assist in the visualization, analysis, and documentation of coronary angiography procedures, supporting real-time decision-making during interventions.
The company’s portfolio is classified under FDA’s Class II regulatory category and is listed in the FDA’s Unique Device Identifier (UDI) database. The products are intended for use within the United States, adhering to applicable medical device regulations.
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 CoroVentis Research AB manufacture?
CoroVentis Research AB specializes in software systems tailored for cardiac catheterization laboratories. Their primary focus is on tools like the CoroFlow platform and its upgrade kits, which are designed to enhance the visualization, analysis, and documentation of coronary angiography procedures. These systems support real-time clinical decision-making during interventions.
Where is CoroVentis Research AB based, and where are their devices intended for use?
CoroVentis Research AB is based in the United States. Their devices are specifically intended for use within the U.S. market, where they must comply with applicable medical device regulations.
Which regulatory registries or databases list CoroVentis Research AB’s devices?
CoroVentis Research AB’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products, ensuring transparency and traceability in compliance with U.S. medical device regulations.
How are CoroVentis Research AB’s devices classified under FDA regulations?
CoroVentis Research AB’s devices fall under the FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as software systems used in cardiac catheterization laboratories.
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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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 352954840
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CoroFlow | 12000 | FDA UDI | Class II | Active |
| CoroFlow Upgrade kit | 12000-20 | FDA UDI | Class II | Active |
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