EUDAMED device

Hyperfil®

EUDAMED device 00810000529667 · Parkell Inc.

Key facts

Primary DI 00810000529667
Trade name Hyperfil®
Device name Hyperfil® 3ml Universal Shade
Reference or catalog number S234
Model S234
Manufacturer Parkell Inc.
Manufacturer SRN US-MF-000003761
Risk class Class IIa
EMDN code Q01010103
EMDN description DENTAL CONSERVATION COMPOSITES
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Mar 12, 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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