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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

AQTIBI001 — Class I MDR by AQUALEG

MD Atlas
AQUALEG

EUDAMED last updated this device on Aug 25, 2025

AQTIBI001

3665988HABILLAGEM2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AQUALEG
UDI-DI code: 03665988000168
Reference / catalog number: AQTIBI001

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Manufacturer information

Organization name: AQUALEG
SRN: FR-MF-000004676
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03665988000168
Basic UDI-DI: 3665988HABILLAGEM2
Reference / catalog number: AQTIBI001
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: L'habillage Aqualeg protège et habille les éléments prothétiques des membres inférieurs pour les activités de tous les jours et pour les activités aquatiques. C’est un accessoire de prothèse de membre inférieur. Il ne peut pas être utilisé par une autre personne que celle pour laquelle ce revêtement a été conçu et fabriqué. Il ne peut pas être utilisé dans la prothèse. L'habillage est en contact avec l'emboiture, l'enveloppe du pied de la prothèse
Additional information URL: https://www.aqualeg.com/fr
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y062703AESTHETIC FILLERS, CALF AND THIGH

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

QRX ADAPTERS3665988ADAPTATEURBBOn the market AQ1/2F3665988HABILLAGEM2On the market AQ1/2F0023665988HABILLAGEM2On the market AQFEM0013665988HABILLAGEM2On the market AQTIBI001M3665988HABILLAGEM2On 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.