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Organization name
UDI-DI code
Reference / catalog number

LESC6SXXZ — Class I MDR by Axiles Bionics BV

MD Atlas
Axiles Bionics BV

EUDAMED last updated this device on May 14, 2025

LESC6SXXZ

54040365PD00003TG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Axiles Bionics BV
UDI-DI code: 05404036502869
Reference / catalog number: LESC6SXXZ

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Manufacturer information

Organization name: Axiles Bionics BV
SRN: BE-MF-000025722
Manufacturer status: Active

Related devices

LESC7SXXZ54040365PD00003TGOn the market LESC3SXXZ54040365PD00003TGOn the market LESC4SXXZ54040365PD00003TGOn the market LESC5SXXZ54040365PD00003TGOn the market LESC2SXXZ54040365PD00003TGOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05404036502869
Basic UDI-DI: 54040365PD00003TG
Reference / catalog number: LESC6SXXZ
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Articulated prosthetic ankle-foot component with spring category C6. The device is intended for the replacement of the ankle and foot function as a component of a prosthesis that compensates for an absent or deficient lower limb.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Left (L) or Right (R)
24–30 MU10

EMDN nomenclature code(s)

Y062409TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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