EUDAMED device
Polysmith 12.2
EUDAMED device 00817111021257 · Neurotronics, LLC
Key facts
| Primary DI | 00817111021257 |
|---|---|
| Device name | Polysmith 12.2 |
| Reference or catalog number | PS12.2 |
| Model | 12.2 |
| Manufacturer | Neurotronics, LLC |
| Manufacturer SRN | US-MF-000030839 |
| Risk class | Class IIa |
| EMDN code | Z12100592 |
| EMDN description | POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 15, 2023 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED)