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Sign in to claim this brandABK Biomedical Incorporated
US
Last updated May 27, 2026
What ABK Biomedical Incorporated makes
ABK Biomedical Incorporated manufactures non-bioabsorbable embolization particles designed for vascular occlusion procedures. Their primary product, the Easi-Vue embolic microspheres System, is intended for use in interventional radiology and neurovascular applications to block blood flow in targeted areas.
The company’s embolization microspheres are classified as Class II medical devices under US regulations and are listed in the FDA’s Unique Device Identification (UDI) database. The products are intended for use within 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 ABK Biomedical Incorporated manufacture?
ABK Biomedical Incorporated specializes in embolization particles that are non-bioabsorbable. These devices are specifically designed for vascular occlusion procedures, meaning they are used to intentionally block blood flow in targeted areas of the body. Their primary focus is on interventional radiology and neurovascular applications.
Where is ABK Biomedical Incorporated based?
ABK Biomedical Incorporated is based in the United States. The company’s products are developed and intended for use within this region.
Which regulatory registries list ABK Biomedical Incorporated’s devices?
ABK Biomedical Incorporated’s embolization devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices authorized for use in the United States.
How are ABK Biomedical Incorporated’s embolization devices classified under US regulations?
ABK Biomedical Incorporated’s embolization microspheres, such as the Easi-Vue embolic microspheres System, are classified as Class II medical devices under US regulations. This classification is based on their intended use for vascular occlusion, where they pose moderate risk and require special controls to ensure safety and effectiveness.
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
- 203463617
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Easi-Vue embolic microspheres System | Administration Kit 150 micron | FDA UDI | Class II | Unknown |
| Easi-Vue embolic microspheres System | EVD100 | FDA UDI | Class II | Active |
| Easi-Vue embolic microspheres System | Refill Syringe 50 micron | FDA UDI | Class II | Active |
| Easi-Vue embolic microspheres System | EVD150 | FDA UDI | Class II | Active |
| Easi-Vue embolic microspheres System | EVD50 | FDA UDI | Class II | Active |
| Easi-Vue embolic microspheres System | Administration Kit 100 micron | FDA UDI | Class II | Unknown |
| Easi-Vue embolic microspheres System | Refill Syringe 100 micron | FDA UDI | Class II | Active |
| Easi-Vue embolic microspheres System | Refill Syringe 150 micron | FDA UDI | Class II | Active |
| Easi-Vue embolic microspheres System | Administration Kit 50 micron | FDA UDI | Class II | Unknown |
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