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Sign in to claim this brandWhat COMPUMEDICS LIMITED makes
The company manufactures medical devices for neurological monitoring and sleep studies, including electroencephalographs (EEG) like the Compumedics Grael and SynAmps RT, as well as polysomnographs such as the Somte for recording brain activity and physiological parameters during sleep. It also produces ambulatory EEG recorders like the Neuvo for portable long-term monitoring, reusable electrical connection cables, reusable pulse oximeter probes, and medical networking interface units like the Okti for data transmission in clinical settings.
All listed devices fall under Class II regulation, requiring performance standards and pre-market notifications. They are included in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- compumedics.com.au
- —
- —
- [email protected]
- Phone
- +61384207386
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 753750967
Catalogue (51)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Compumedics Grael | Grael LT | FDA UDI | Class II | Active |
| Compumedics Somte | Somte | FDA UDI | Class II | Active |
| Compumedics SynAmps RT | SynAmps RT | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Wall Mount Assembly | FDA UDI | Class II | Active |
| Compumedics Okti | Okti 128 | FDA UDI | Class II | Active |
| Compumedics Grael | Grael | FDA UDI | N/A | Active |
| Compumedics Grael | Grael EEG | FDA UDI | Class II | Active |
| Compumedics SynAmps RT | SynAmps RT | FDA UDI | Class II | Active |
| Compumedics Okti | Okti 32 | FDA UDI | Class II | Active |
| Compumedics Somte | 7023-0006-01 | FDA UDI | Class II | Active |
| Compumedics Somte | 7023-0005-01 | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Cable Control Unit, 2 meters | FDA UDI | Class II | Active |
| Compumedics Grael | Grael LT | FDA UDI | Class II | Active |
| Compumedics Grael | Grael EEG | FDA UDI | Class II | Active |
| Compumedics Somte | Somte | FDA UDI | Class II | Active |
| Compumedics | 7028-0006-02 | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo LTM Module | FDA UDI | Class II | Active |
| Compumedics Grael | Grael | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Headbox 128Ch | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo 128 Ch Headbox Bracket | FDA UDI | Class II | Active |
| Compumedics | 8028-0022-01 | FDA UDI | Class II | Active |
| Compumedics Grael | Grael PSG | FDA UDI | Class II | Active |
| Compumedics SynAmps RT | SynAmps RT | FDA UDI | Class II | Active |
| Compumedics Grael | Grael | FDA UDI | Class II | Active |
| Compumedics | 8022-0063-01 | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo LTM Module Assembly | FDA UDI | Class II | Active |
| Compumedics Grael | Grael Cradle | FDA UDI | Class II | Active |
| Compumedics Somte | Somte | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Bracket LTM Headbox | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo System Wall Mnt 64 Ch LTM | FDA UDI | Class II | Active |
| Compumedics Grael | 8028-0100-02 | FDA UDI | Class II | Active |
| Compumedics Somte | Somte | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Headbox Assembly | FDA UDI | Class II | Active |
| Compumedics Somte | Somte PSG v2 | FDA UDI | Class II | Active |
| Compumedics | 7000-0270-00 | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo-Bracket Event Button | FDA UDI | Class II | Active |
| Compumedics Grael | Grael EEG | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo System Unit Assembly | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Bracket - Headbox Mount | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Headbox (Amplifier) 64 Ch - Wall Column Kit | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Bracket - Headbox System Mounting Kits | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Cable - LTM to Amplifier | FDA UDI | Class II | Active |
| Compumedics Grael | Grael LT | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo LTM Harness Cover | FDA UDI | Class II | Active |
| Compumedics SynAmps RT | SynAmps RT | FDA UDI | Class II | Active |
| Compumedics Neuvo | Neuvo Bracket - System Unit | FDA UDI | Class II | Active |
| Compumedics SynAmps RT | SynAmps RT | FDA UDI | Class II | Active |
| Compumedics Grael | Grael PSG | FDA UDI | Class II | Active |
| Compumedics SynAmps RT | SynAmps RT | FDA UDI | Class II | Active |
| Compumedics Somte | Somte PSG v2 | FDA UDI | Class II | Active |
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