EUDAMED device

Laser Handpiece

EUDAMED device 00647529002278 · BIOLASE, Inc.

Key facts

Primary DI 00647529002278
Trade name Laser Handpiece
Device name Gold Handpiece
Reference or catalog number 6200500
Model 6200500
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 26, 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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