EUDAMED device

Sphinx HB710 Head Box

EUDAMED device 00817111020335 · Neurotronics, LLC

Key facts

Primary DI 00817111020335
Device name Sphinx HB710 Head Box
Reference or catalog number HB710
Model Sphinx PMU710
Manufacturer Neurotronics, LLC
Manufacturer SRN US-MF-000030839
Risk class Class IIa
EMDN code Z12100501
EMDN description POLYSOMNOGRAPHS
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Aug 15, 2023

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)

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