Standard Back Skin M

by BioSkin LLC EUDAMED

Withdrawn No longer placed on the EU market

Ref 47102

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Withdrawn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European Union — CE/MDR Withdrawn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: 47102

Primary DI / UDI-DI: 00647552503865
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