Easy Skin Cover w/ Hair

by Alps South, LLC 8 variants

Ref TSKH-11-S

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number07139801000301078 Basic UDI-DI 00713980003632UDI-DI	Date22 Feb 2024Registered	StatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name: Easyskin
Model / Reference: TSKH-11-S

Primary DI / UDI-DI: 00713980003632
Basic UDI-DI: 07139801000301078
EMDN Code: Y062409 Transtibial prostheses (for amputation under knee)

Device Class: Class I
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: US-MF-000001260
Authorised representative: AR Experts B.V. NL-AR-000023989

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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