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Sign in to claim this brandCARDIAC INSIGHT, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2375 130th Ave NE, Bellevue, WA, 98005
- 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
- 3010342616
- DUNS Number
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Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cardea SOLO | M300-5 | FDA UDI | Class II | Active |
| Cardea 20/20 ECG | CS-2020-B | FDA UDI | Class II | Active |
| Cardea SOLO | D300 | FDA UDI | Class II | Active |
| Stealth System S300 | M300-5 | FDA UDI | Class II | Unknown |
| Stealth System S300 | C300/D300 | FDA UDI | Class II | Unknown |
| Cardea SOLO | C300/D300 | FDA UDI | Class II | Active |
| CardeaScreen | CS-2020-A | FDA UDI | Class II | Unknown |
| Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | K142468 | FDA 510(k) | Class II | Active |
| Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | K162503 | FDA 510(k) | Class II | Active |
| Stealth Monitor, Stealth Docking Cable, Stealth Display And Storage Device | K130288 | FDA 510(k) | Class II | Active |
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