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United States·US-MF-000029146
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 189, N Bernardo Ave, Mountain View, United States
- Website
- www.kardia.com/
- —
- —
- [email protected]
- Phone
- +1 785 760 4019
- PRRC Contact
- Shawn Maxwell
- EUDAMED SRN
- US-MF-000029146
- FDA FEI Number
- 3009715978
- DUNS Number
- —
Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KardiaStation 12L (iOS) | 002019 | EUDAMED | Class IIb | Active |
| KardiaStation 12L (Android) | 002020 | EUDAMED | Class IIb | Active |
| K1000 | AC-029 | FDA UDI | Class II | Active |
| KardiaMobile 6L | AC-019 | FDA UDI | Class II | Active |
| Kardia Mobile | AC-009 | FDA UDI | Class II | Active |
| KardiaMobile Card | AC-021 | FDA UDI | Class II | Active |
| KardiaBand System | AC-011 | FDA UDI | Class II | Unknown |
| Kardia 12L | AC-027 | FDA UDI | Class II | Active |
| AliveCor QT Service | K212662 | FDA 510(k) | Class II | Active |
| KardiaMobile 6L | K220350 | FDA 510(k) | Class II | Active |
| Triangle System | K183319 | FDA 510(k) | Class II | Active |
| KardiaMobile Card | K211668 | FDA 510(k) | Class II | Active |
| KardiaMobile, KardiaStation | K191406 | FDA 510(k) | Class II | Active |
| KardiaAI | K181823 | FDA 510(k) | Class II | Active |
| Alivecor Heart Monitor Otc | K130921 | FDA 510(k) | Class II | Active |
| Alivecor Heart Monitor For Iphone | K122356 | FDA 510(k) | Class II | Active |
| KardiaAI | K201985 | FDA 510(k) | Class II | Active |
| Alivecor Heart Monitor | K140933 | FDA 510(k) | Class II | Active |
| Alivecor Heart Monitor | K130409 | FDA 510(k) | Class II | Active |
| Corvair | K231010 | FDA 510(k) | Class II | Active |
| KardiaMobile 6L | K210753 | FDA 510(k) | Class II | Active |
| Impala | K232035 | FDA 510(k) | Class II | Active |
| Kardia Band System | K171816 | FDA 510(k) | Class II | Active |
| AliveCor Heart Monitor | K142672 | FDA 510(k) | Class II | Active |
| KardiaMobile, KardiaStation | K182396 | FDA 510(k) | Class II | Active |
| Corvair Monza | K252589 | FDA 510(k) | Class II | Active |
| AliveCor Heart Monitor | K142743 | FDA 510(k) | Class II | Active |
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