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Organization name
UDI-DI code
Reference / catalog number

LESC4SXXZ — Class I MDR by Axiles Bionics BV

MD Atlas
Axiles Bionics BV

EUDAMED last updated this device on May 14, 2025

LESC4SXXZ

54040365PD00003TG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Axiles Bionics BV
UDI-DI code: 05404036502845
Reference / catalog number: LESC4SXXZ

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Manufacturer information

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

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LESC7SXXZ54040365PD00003TGOn the market LESC6SXXZ54040365PD00003TGOn the market LESC3SXXZ54040365PD00003TGOn 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: 05404036502845
Basic UDI-DI: 54040365PD00003TG
Reference / catalog number: LESC4SXXZ
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 C4. 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: 24–30 MU10
Left (L) or Right (R)

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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