EUDAMED device

Waterlase MDX 300 Laser System

EUDAMED device 00647529000304 · BIOLASE, Inc.

Key facts

Primary DI 00647529000304
Trade name Waterlase MDX 300 Laser System
Device name Waterlase MDX 300
Reference or catalog number 7200861-06
Model 7200861-06
Manufacturer BIOLASE, Inc.
Manufacturer SRN US-MF-000028587
Risk class Class IIb
EMDN code Z12011014
EMDN description ERBIUM 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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