EUDAMED device

Black Preflex Sleeve Size 20 w/Reinforced Fabric

EUDAMED device 00713980037361 · Alps South, LLC

Key facts

Primary DI 00713980037361
Trade name Black Preflex Sleeve Size 20 w/Reinforced Fabric
Device name REINFORCED SLEEVE
Reference or catalog number RFX20-3BL
Manufacturer Alps South, LLC
Manufacturer SRN US-MF-000001260
Risk class Class I
EMDN code Y062409
EMDN description TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Apr 3, 2025

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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