EUDAMED device

Laser Handpiece

EUDAMED device 00647529000151 · BIOLASE, Inc.

Key facts

Primary DI 00647529000151
Trade name Laser Handpiece
Device name Surgical Handpiece, 1Pk
Reference or catalog number 6400105
Model 6400105
Manufacturer BIOLASE, Inc.
Manufacturer SRN US-MF-000028587
Risk class Class I
EMDN code Z12011099
EMDN description LASER SURGERY INSTRUMENTS - OTHER
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Feb 23, 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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