EUDAMED device

BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit

EUDAMED device 00810633022092 · Synthes GmbH

Key facts

Primary DI 00810633022092
Device name BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit
Reference or catalog number DK-265C
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:

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