EUDAMED device

Intraocular Lens

EUDAMED device 00810109290000 · Simedice Biotechnologies Inc.

Key facts

Primary DI 00810109290000
Device name Intraocular Lens
Reference or catalog number US-SM60AS
Model SM60AS, SM60AS1, SM60AS2, SM60AS3
Manufacturer Simedice Biotechnologies Inc.
Manufacturer SRN US-MF-000017961
Risk class Class IIb
EMDN code P030102090201
EMDN description IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Legislation mdd
Implantable Yes
Sterile Yes
Single use Yes
Status date Oct 30, 2023

At a glance

  • No 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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