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Sign in to claim this brandEmbla Systems
US
Last updated May 23, 2026
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- US
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Catalogue (40)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Xltek | 012001 | FDA UDI | Class II | Active |
| Xltek | 1421036 | FDA UDI | Class II | Active |
| Xltek | 2003010 | FDA UDI | Class II | Active |
| Xltek | 1421023 | FDA UDI | Class II | Active |
| Xltek | 2013031 | FDA UDI | Class II | Active |
| Xltek | 1430000 | FDA UDI | Class II | Active |
| Xltek | 1421039 | FDA UDI | Class II | Active |
| Xltek | 1421038 | FDA UDI | Class II | Active |
| Xltek | 1249014 | FDA UDI | Class II | Active |
| Xltek | 1421041 | FDA UDI | Class II | Active |
| Xltek | 013974 | FDA UDI | Class II | Active |
| Xltek | 2013030 | FDA UDI | Class II | Active |
| Xltek | 1421040 | FDA UDI | Class II | Active |
| Embla | 025406 | FDA UDI | Class II | Active |
| Xltek | 1421042 | FDA UDI | Class II | Active |
| Xltek | 1421034 | FDA UDI | Class II | Active |
| Xltek | 2013032 | FDA UDI | Class II | Active |
| Natus | 1421027 | FDA UDI | Class II | Active |
| Xltek | 1421035 | FDA UDI | Class II | Active |
| Xltek | 1421032 | FDA UDI | Class II | Active |
| Natus | 1421045 | FDA UDI | Class II | Active |
| Xltek | 1411546 | FDA UDI | Class II | Active |
| Xltek | 2003011 | FDA UDI | Class II | Active |
| Xltek | 1421033 | FDA UDI | Class II | Active |
| Xltek | 4120082 | FDA UDI | Class II | Active |
| Natus | 1421026 | FDA UDI | Class II | Active |
| Xltek | 4283000 | FDA UDI | Class II | Active |
| Xltek | 1421044 | FDA UDI | Class II | Active |
| Xltek | 1421037 | FDA UDI | Class II | Active |
| Xltek | 1421043 | FDA UDI | Class II | Active |
| Xltek | 011291 | FDA UDI | Class II | Active |
| Sandman Elite | K153353 | FDA 510(k) | Class II | Active |
| RemLogic | K162140 | FDA 510(k) | Class II | Active |
| Mdrive | K111742 | FDA 510(k) | Class II | Active |
| Disposable Snap Electrode | K172703 | FDA 510(k) | Class II | Active |
| REMbrandt | K163617 | FDA 510(k) | Class II | Active |
| XactTrace Single Use Respiratory Effort Belt System | K173793 | FDA 510(k) | Class II | Active |
| Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | K180001 | FDA 510(k) | Class II | Active |
| Embletta Gold | K073682 | FDA 510(k) | Class II | Active |
| Embletta Mpr | K122516 | FDA 510(k) | Class II | Active |
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