EUDAMED device
BME ELITE
EUDAMED device 00810633021965 · Synthes GmbH
Key facts
| Primary DI | 00810633021965 |
|---|---|
| Trade name | BME ELITE |
| Device name | BME ELITE and BME ELITE Y Drill Guide Kit |
| Reference or catalog number | EL-DTS |
| Model | BME ELITE and BME ELITE Y Drill Guide Kit |
| Manufacturer | Synthes GmbH |
| Manufacturer SRN | CH-MF-000013345 |
| Risk class | Class IIa |
| EMDN code | Z12139099 |
| EMDN description | VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Jul 31, 2025 |
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: