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BIEMME GROUP SRL

Italy IT-MF-000031381 Last updated 21 Oct 2026

Devices
15
Registries
EUDAMED
FDA recalls
0

Catalogue15

  • Wally Ref WALLY S2

    Class I EUDAMED Active

  • Felix Ref Felix-22

    Class I EUDAMED Active

  • Felix Ref Felix-20X

    Class I EUDAMED Active

  • Leo Ref LEO M2

    Class I EUDAMED Active

  • Leo Ref LEONCINO M1

    Class I EUDAMED Active

  • Wally Ref Wally P3

    Class I EUDAMED Active

  • Leo Ref LEONCINO M2

    Class I EUDAMED Active

  • Felix Ref Felix-18

    Class I EUDAMED Active

  • Felix Ref Felix-20

    Class I EUDAMED Active

  • Jupiter Ref JUPITER BIG

    Class I EUDAMED Active

  • Leo Ref LEO M1

    Class I EUDAMED Active

  • Elephant Ref ELEPHANT 2.0 BS

    Class I EUDAMED Active

  • Wally Ref Wally S3

    Class I EUDAMED Active

  • Jupiter Ref Jupiter

    Class I EUDAMED Active

  • Wally Ref Wally P1

    Class I EUDAMED Active

About

Biemme Group Srl is dedicated to creating orthopaedic help for children with complex disabilities. Felix, Elephant, Jupiter, Wally and Leo are the tools we offer, for tailor-made solutions for every need.

Translated from the manufacturer's own website. Source

What BIEMME GROUP SRL makes

Biemme Group Srl manufactures orthopaedic devices designed for children with complex disabilities, including customisable supports named Felix, Elephant, Jupiter, Wally, and Leo. These products are intended to provide tailored mobility and positioning solutions for paediatric patients with specific physical needs.

The company’s devices are classified under EU Medical Device Regulation as Class I and are registered in the EUDAMED database. Biemme Group Srl operates from Italy, adhering to EU regulatory requirements for medical devices.

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 Biemme Group Srl manufacture?

Biemme Group Srl specialises in orthopaedic devices tailored for children with complex disabilities. Their product range includes customisable supports such as Felix, Elephant, Jupiter, Wally, and Leo. These devices are designed to assist with mobility, positioning, and functional support for paediatric patients with specific physical limitations.

Where is Biemme Group Srl based, and how does this affect its devices?

Biemme Group Srl is based in Italy, which means its devices comply with the European Union’s regulatory framework for medical devices. Since their products are classified under EU Medical Device Regulation as Class I, they must meet EUDAMED registration requirements, ensuring traceability and transparency in the European market.

Are Biemme Group Srl’s devices listed in any regulatory databases?

Yes, Biemme Group Srl’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures that their products are accounted for under EU regulatory oversight, particularly for Class I devices, which still require documentation and traceability to maintain compliance.

How are Biemme Group Srl’s devices classified under EU regulations?

Biemme Group Srl’s devices fall under Class I classification according to the EU Medical Device Regulation. This classification is typically assigned to low-risk devices, such as orthopaedic supports for children with disabilities, where the risk of harm is minimal. However, even Class I devices must meet essential safety and performance requirements and be registered in systems like EUDAMED.

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

Information

Country
Italy
Address
5, Via Ugo la Malfa, RUBIERA, Italy
Phone
+3905221493390
PRRC contact
IVANO CERRI
EUDAMED SRN
IT-MF-000031381