EUDAMED device

BIO | Max Implant Driver Handpiece NP Long

EUDAMED device 00815131028997 · Blue Sky Bio, LLC

Key facts

Primary DI 00815131028997
Trade name BIO | Max Implant Driver Handpiece NP Long
Device name DRIVER
Reference or catalog number DMJHL
Manufacturer Blue Sky Bio, LLC
Manufacturer SRN US-MF-000014016
Risk class Class I
EMDN code Q010399
EMDN description SURGICAL DENTAL DEVICES - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Mar 27, 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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