EUDAMED device

(46-51 cm) Reinforced Sleeve Black

EUDAMED device 00713980001706 · Alps South, LLC

Key facts

Primary DI 00713980001706
Trade name (46-51 cm) Reinforced Sleeve Black
Device name SILICONE SLEEVE
Reference or catalog number SLR-3XL-BL
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 Dec 24, 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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