EUDAMED device

AFX Introducer

EUDAMED device 00818009011381 · Endologix LLC

Key facts

Primary DI 00818009011381
Trade name AFX Introducer
Device name AFX Introducer System
Reference or catalog number F00511
Model S17-45
Manufacturer Endologix LLC
Manufacturer SRN US-MF-000010201
Risk class Class III
EMDN code C0502
EMDN description CARDIOVASCULAR INTRODUCER SHEATHS, VALVED
Legislation mdd
Implantable Yes
Sterile Yes
Single use Yes
Status date Feb 10, 2022

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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