Standard Back Skin Xs

by BioSkin LLC EUDAMED

Withdrawn No longer placed on the EU market

Ref 47100

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0647552BACKSKINSC 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Withdrawn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European Union — CE/MDR Withdrawn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: Standard Back Skin
Model / Reference: 47100

Primary DI / UDI-DI: 00647552503841
Basic UDI-DI: 0647552BACKSKINSC
EMDN Code: Y060308 Lumbosacral spine orthoses

Device Class: Class I

Manufacturer details

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

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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