EUDAMED device
Ultium Insole SmartLead
EUDAMED device 00816271020476 · Noraxon USA, Inc.
Key facts
| Primary DI | 00816271020476 |
|---|---|
| Trade name | Ultium Insole SmartLead |
| Device name | Wireless EMG Family Accessories |
| Reference or catalog number | 826 |
| Manufacturer | Noraxon USA, Inc. |
| Manufacturer SRN | US-MF-000003882 |
| Risk class | Class I |
| EMDN code | Z12100480 |
| EMDN description | ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Feb 21, 2024 |
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) · Source date: