EUDAMED device

"Analog Implant Level Internal Octagon - Regular Platform

EUDAMED device 00815131028560 · Blue Sky Bio, LLC

Key facts

Primary DI 00815131028560
Trade name "Analog Implant Level Internal Octagon - Regular Platform
Device name ANALOG
Reference or catalog number BOR48
Manufacturer Blue Sky Bio, LLC
Manufacturer SRN US-MF-000014016
Risk class Class I
EMDN code Q010207
EMDN description DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY
Legislation mdr
Implantable No
Sterile No
Single use Yes
Status date Apr 1, 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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