EUDAMED device

Epic X Diode Laser System

EUDAMED device 00647529000175 · BIOLASE, Inc.

Key facts

Primary DI 00647529000175
Trade name Epic X Diode Laser System
Device name Epic X
Reference or catalog number 7400073
Model 7400073
Manufacturer BIOLASE, Inc.
Manufacturer SRN US-MF-000028587
Risk class Class IIb
EMDN code Z12011016
EMDN description DIODE SURGICAL LASER
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Feb 20, 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:

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