Standard Ankle Support - with Criss Cross Bandage- Universal

by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇

Ref ARA5400-STD

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number868085311ARMALLL6 Basic UDI-DI 08680853107167UDI-DI	Date28 Nov 2024Registered	StatusActive

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Withdrawn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 Active

Specification

EUDAMED

Device Name: Armall
Model / Reference: ARA5400-STD

Primary DI / UDI-DI: 08680853107167
Basic UDI-DI: 868085311ARMALLL6
Direct Marketing DI: 08680853107167
EMDN Code: Y06120601 Passive ankle-foot orthoses

Device Class: Class I
EU market of registration: Türkiye

Manufacturer details

EUDAMED SRN: TR-MF-000030874

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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