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Sign in to claim this brandDirex Systems Corp.
US
Last updated May 24, 2026
What Direx Systems Corp. makes
Direx Systems Corp. manufactures electromechanical and spark-gap extracorporeal lithotripsy systems used for medical procedures. The company also produces fluoroscopic x-ray system video image recording units and associated imaging and tracking components.
The company is based in the United States, and its portfolio consists of Class II medical devices. These products are listed in the FDA 510(k) clearance database and the FDA Unique Device Identification (UDI) system.
Written from this company's registered devices by an AI model, 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
- 837501337
Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Integra | INTEGRA | FDA UDI | Class II | Active |
| 3dscope | 3DSCOPE | FDA UDI | Class II | Active |
| Tripter X-1 Compact | COMPACT | FDA UDI | Class II | Active |
| Duet Magna | MAGNA | FDA UDI | Class II | Active |
| Compact Duet | COMPACT DUET | FDA UDI | Class II | Active |
| Pronex | K102765 | FDA 510(k) | Class II | Active |
| Accusoft | K040474 | FDA 510(k) | Class II | Active |
| Trackport | K072529 | FDA 510(k) | Class II | Active |
| Integra Sl | K062147 | FDA 510(k) | Class II | Active |
| Tripter X-1 Compact | K040470 | FDA 510(k) | Class II | Active |
| Accuchanger | K043409 | FDA 510(k) | Class II | Active |
| Migue | K052212 | FDA 510(k) | Class II | Active |
| Accusoft | K032171 | FDA 510(k) | Class II | Active |
| Vert-X | K061873 | FDA 510(k) | Class II | Active |
| Trackleaf-10 | K071701 | FDA 510(k) | Class II | Active |
| Dart-12 | K052705 | FDA 510(k) | Class II | Active |
| Acculeaf | K021338 | FDA 510(k) | Class II | Active |
| Magis1;magis2 | K061713 | FDA 510(k) | Class II | Active |
| Modification To Acculeaf | K040553 | FDA 510(k) | Class II | Active |
| Tripter-X1 Compact Duet Sp (separated Pulse) | K050091 | FDA 510(k) | Class II | Active |
| Duet Magna | K111947 | FDA 510(k) | Class II | Active |
| Tripter X-1 Compact Duet | K023535 | FDA 510(k) | Class II | Active |
| Accusoft, Accusoft Xl | K062032 | FDA 510(k) | Class II | Active |
| Crossplan / Accusoft-Xl V.4.04 | K063482 | FDA 510(k) | Class II | Active |
| Integra | K053640 | FDA 510(k) | Class II | Active |
| 3dscope | K041213 | FDA 510(k) | Class II | Active |
| Modification To Tripter X-1 Compact Duet | K041582 | FDA 510(k) | Class II | Active |
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