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Sign in to claim this brandDATRIX LLC
US
Last updated May 27, 2026
Information
- Country
- US
- Address
- —
- Website
- intricon.com
- —
- —
- [email protected]
- Phone
- 651-636-9770
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080555401
Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HeartcoR | Sentinel | FDA UDI | Class II | Active |
| Vx3+ | VX3+ Series M | FDA UDI | Class II | Active |
| Datrix | VX3+ Series T | FDA UDI | Class II | Active |
| Ami | RX93030-001 | FDA UDI | Class II | Active |
| Vx3+ | VX3+ Series C | FDA UDI | Class II | Active |
| A.C.T. (American Cardiac Telemetry) | Sirona | FDA UDI | Class II | Active |
| Sirona | RX93030-000 | FDA UDI | Class II | Active |
| BodyGuardian | VX3+ Series R | FDA UDI | Class II | Active |
| Broomwell | Sirona | FDA UDI | Class II | Active |
| Performer + | RX92887-000 | FDA UDI | Class II | Active |
| CardioLabs | Sirona | FDA UDI | Class II | Active |
| Heart Smart | Sirona | FDA UDI | Class II | Active |
| Ami | Sirona | FDA UDI | Class II | Active |
| CardioDiagnostics | Lifesense mini | FDA UDI | Class II | Active |
| Cardiostaff | Sirona | FDA UDI | Class II | Active |
| A.C.T. (American Cardiac Telemetry) | Sirona | FDA UDI | Class II | Active |
| Sirona | RX22673 | FDA UDI | Class II | Active |
| Sirona | RX93051-000 | FDA UDI | Class II | Unknown |
| Sirona | RX22674 | FDA UDI | Class II | Active |
| Datrix | VX3+ Series L | FDA UDI | Class II | Active |
| Broomwell | Sirona | FDA UDI | Class II | Active |
| CardioLabs | Sirona | FDA UDI | Class II | Active |
| Vx3+ | VX3+ Series Hatco | FDA UDI | Class II | Active |
| Cardiostaff | Sirona | FDA UDI | Class II | Active |
| Ami | Sirona | FDA UDI | Class II | Active |
| TLC Diagnostics | TLC 1-Stop Alert | FDA UDI | Class II | Active |
| Zywie | Sirona | FDA UDI | Class II | Active |
| Sirona | RX22711 | FDA UDI | Class II | Active |
| CardioHolter | VX3+ Series A | FDA UDI | Class II | Active |
| CardioLabs | RX93030-002 | FDA UDI | Class II | Active |
| Vx3+ | VX3+ Series H | FDA UDI | Class II | Active |
| Sirona | RX92864-000 | FDA UDI | Class II | Active |
| CardioLabs | Sirona | FDA UDI | Class II | Active |
| Vx3+ | VX3+ Series CDM | FDA UDI | Class II | Active |
| Vx3+ | VX3+ Series P | FDA UDI | Class II | Active |
| Digital Ambulatory Ecg (holter) Recorder | K031074 | FDA 510(k) | Class II | Active |
| Digital Ecg Holter Recorder, Model Dr512 | K982975 | FDA 510(k) | Class II | Active |
| Datrix Cardio Wifi Electrocardiograph | K053083 | FDA 510(k) | Class II | Active |
| Gikter Ecg Cassette Tape Recorder Model Xr 300 | K921068 | FDA 510(k) | Class II | Active |
| Cardioserver | K052883 | FDA 510(k) | Class II | Active |
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