Ankle Sleeve Wrap XXL

by BioSkin LLC EUDAMED

Withdrawn No longer placed on the EU market

Ref 53515

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0647552ANKLESLEEVELF Basic UDI-DI	Date6 Oct 2026Registered	StatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: Ankle Sleeve Wrap
Model / Reference: 53515

Primary DI / UDI-DI: 00647552514120
Basic UDI-DI: 0647552ANKLESLEEVELF
EMDN Code: Y06120601 Passive ankle-foot orthoses

Device Class: Class I

Manufacturer details

EUDAMED SRN: US-MF-000016322
Authorised representative: Rollerwerk Medical Engineering & Consulting DE-AR-000015883

Other devices from BioSkin LLC

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Knee Sleeve XL

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OA Spiral L

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Patella Stabilisator Xs

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Trilok M

Class I
OA Spiral XXL

Class I

See all devices from BioSkin LLC →

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No