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United States·US-MF-000007439
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 215, Fremont St., San Francisco, United States
- —
- —
- [email protected]
- Phone
- United States: +1 877 623 4997 Canada: +1 877 623-4997 UK: +448000265911 Ireland: +35316917502
- PRRC Contact
- Adam Vasquez
- EUDAMED SRN
- US-MF-000007439
- FDA FEI Number
- 3009253624
- DUNS Number
- 829454672
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Google ECG app | GA13098 | EUDAMED | Class IIa | Active |
| Google Irregular Rhythm Notifications | GA13099 | EUDAMED | Class IIa | Active |
| Aria 2 Wi-Fi Smart Scale | FB202 | FDA UDI | Class II | Active |
| Aria | FB201B | FDA UDI | Class II | Unknown |
| Aria 2 Wi-Fi Smart Scale | FB202 | FDA UDI | Class II | Active |
| Fitbit Irregular Rhythm Notifications | FB604 | FDA UDI | Class II | Active |
| Aria | FB201W | FDA UDI | Class II | Unknown |
| Aria | FB201B2 | FDA UDI | Class II | Unknown |
| Body Temperature Software (BTS) | K243778 | FDA 510(k) | Class II | Active |
| Aria Wifi Smart Scale | K133872 | FDA 510(k) | Class II | Active |
| Fitbit Irregular Rhythm Notifications | K212372 | FDA 510(k) | Class II | Active |
| Loss of Pulse Detection | FB612 | EUDAMED | Class IIa | Active |
| Body Temperature Software | FB611 | EUDAMEDFDA 510(k) | Class IIa | Active |
| Fitbit ECG App | FB603 | EUDAMEDFDA UDI | Class IIa | Active |
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