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AQUALEG

France FR-MF-000004676 Last updated 21 Oct 2026

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Devices
138
Registries
EUDAMED
FDA recalls
0

Catalogue138

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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    Class I EUDAMED Active

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About

AQUALEG, creator of the Soft Shell Extreme Cover for tibial and femoral prostheses. High durability, suitable for suspension sleeves, easy access for adjustments.

From the manufacturer's own website. Source

What AQUALEG makes

The manufacturer produces soft-shell suspension covers designed to fit over tibial and femoral prosthetic components. These covers are intended to provide durability and ease of use, including quick access for adjustments and compatibility with suspension sleeves.

The products fall under EU Medical Device Regulation as Class I devices and are registered in the EUDAMED database. The company is based in France.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does AQUALEG manufacture?

AQUALEG manufactures soft-shell suspension covers specifically designed to fit over tibial and femoral prosthetic components. These covers are intended to enhance durability and usability, such as providing easy access for adjustments and compatibility with suspension sleeves. The devices are tailored for prosthetic limb applications.

Where is AQUALEG based, and what country regulates its devices?

AQUALEG is based in France. Its devices are regulated under the EU Medical Device Regulation, which applies to manufacturers operating within the European Union. Compliance with this regulation ensures that the products meet the necessary safety, performance, and quality standards for the EU market.

Are AQUALEG’s devices listed in any regulatory registries?

Yes, AQUALEG’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry is used to track and provide transparency on medical devices authorized for placement on the EU market, including their classification and regulatory status.

How are AQUALEG’s devices classified under EU regulations?

AQUALEG’s devices are classified as Class I under the EU Medical Device Regulation. This classification is typically assigned to low-risk devices, such as certain accessories or protective covers, where the risk to patients is minimal. The classification determines the regulatory requirements for manufacturing, labeling, and post-market surveillance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
France
Address
3, Rue du Tibre, THOUARE SUR LOIRE, France
Phone
+33 2 28 23 67 33
PRRC contact
FREDERIC RAUCH
EUDAMED SRN
FR-MF-000004676