EUDAMED device

Unity

EUDAMED device 00380650003935 · Alcon Laboratories, Inc.

Key facts

Primary DI 00380650003935
Trade name Unity
Device name Viscous Fluid Control (VFC) Pak
Reference or catalog number 8065000393
Manufacturer Alcon Laboratories, Inc.
Manufacturer SRN US-MF-000016248
Risk class Class IIa
EMDN code Z12120285
EMDN description THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES
Legislation mdr
Implantable No
Sterile Yes
Single use Yes
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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