EUDAMED device
BME SPEED
EUDAMED device 00810633021835 · Synthes GmbH
Key facts
| Primary DI | 00810633021835 |
|---|---|
| Trade name | BME SPEED |
| Device name | BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit |
| Reference or catalog number | DK-200HW |
| Model | BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit |
| 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: