Lunaris IO

by Axiles Bionics BV Belgium EUDAMED

Ref LUNC6SXXZ, LUNC4SXXZ, LUNC5SXXZModel Lunaris IO EMDN Y062409

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number54040365PD00001TC Basic UDI-DI	Date9 Nov 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: Lunaris IO, LUNC6SXXZ, LUNC4SXXZ, LUNC5SXXZ

Primary DI / UDI-DI: 05404036500155, 05404036500131, 05404036500148
Basic UDI-DI: 54040365PD00001TC
EMDN Code: Y062409 Transtibial prostheses (for amputation under knee)

Device Class: Class I
Market of Registration: Belgium

Manufacturer details

EUDAMED SRN: BE-MF-000025722

Other devices from Axiles Bionics BV

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Lunaris Essential

Class I
Lunaris Essential

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Lunaris Essential

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See all devices from Axiles Bionics BV →

Properties & raw data

Show properties, registry sources and raw records

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

Sources (3)

EUDAMED af35ff2f-f7dd-41c0-954e-752784c587c1 61 fields · synced 22 Oct 2026
EUDAMED 05404036500131|54040365PD00001TC 61 fields · synced 17 May 2026
EUDAMED 05404036500148|54040365PD00001TC 61 fields · synced 18 May 2026