Hinged Knee Sleeve XXL

by BioSkin LLC EUDAMED

Withdrawn No longer placed on the EU market

Ref 61305O

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0647552HINGEDKNEETY 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Withdrawn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European Union — CE/MDR Withdrawn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: Hinged Knee Sleeve
Model / Reference: 61305O

Primary DI / UDI-DI: 00647552515622
Basic UDI-DI: 0647552HINGEDKNEETY
EMDN Code: Y061209 Knee 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

Knee Sleeve L

Class I
Knee Sleeve XL

Class I
OA Spiral L

Class I
Patella Stabilisator Xs

Class I
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