EUDAMED device

NGENUITY

EUDAMED device 00380650001139 · Alcon Laboratories, Inc.

Key facts

Primary DI 00380650001139
Trade name NGENUITY
Device name NGENUITY 1.4
Reference or catalog number 8065000113
Manufacturer Alcon Laboratories, Inc.
Manufacturer SRN US-MF-000016248
Risk class Class I
EMDN code Z12011101
EMDN description OPERATIVE MICROSCOPES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Jan 8, 2026

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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