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Andanza International

Germany DE-MF-000014213 Last updated 21 Oct 2026

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Devices
10
Registries
EUDAMED
FDA recalls
0

Catalogue10

  • Premofix Ref DV1035R

    Class I EUDAMED Active

  • Premofix Ref DV1082T

    Class I EUDAMED Active

  • Arteo Air Plus size 6 Ref POS2060

    Class I EUDAMED Active

  • Premofix Ref K1012UX

    Class I EUDAMED Active

  • Premofix Ref K1010H

    Class I EUDAMED Active

  • Premofix Ref K1010RO

    Class I EUDAMED Active

  • Arteo Ref POS2040

    Class I EUDAMED Active

  • Arteo Ref POS2050

    Class I EUDAMED Active

About

Andanza offers innovative and high-quality bandages, fast-pressure systems and compression products for the aftercare of puncture points.

Translated from the manufacturer's own website. Source

What Andanza International makes

Andanza International manufactures adhesive bandages, fast-pressure systems, and compression products designed for post-procedure aftercare of puncture sites. Their portfolio includes products like the Arteo and Arteo Air Plus series, which are tailored for specific sizes, as well as Premofix bandages for secure wound closure. The company also produces abdominal compression products, such as the Andanza Eco Abdominal Gr. 5, for post-operative support.

All listed devices fall under EU Class I classification and are registered in the EU’s eudamed database. The manufacturer is based in Germany and adheres 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 Andanza International manufacture?

Andanza International specializes in adhesive bandages, fast-pressure systems, and compression products. These devices are primarily designed for the aftercare of puncture sites, such as those used in medical procedures like catheter insertions or minor surgical interventions. Examples include the Arteo and Arteo Air Plus series (available in specific sizes), Premofix bandages for secure wound closure, and the Andanza Eco Abdominal Gr. 5 for post-operative abdominal compression.

Where is Andanza International based, and what regulatory requirements do they follow?

Andanza International is based in Germany. Their devices are developed and marketed in compliance with EU medical device regulations, ensuring they meet the necessary safety, performance, and quality standards for the European market.

Which regulatory registries list Andanza International’s devices?

Andanza International’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This platform ensures transparency and traceability of devices authorized for use within the European Economic Area.

How are Andanza International’s devices classified under EU regulations?

All of Andanza International’s listed devices fall under EU Class I classification. This classification applies to low-risk medical devices, such as bandages and compression products, which are deemed to pose minimal risk to patients when used as intended.

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

Information

Country
Germany
Address
4, Zum Werrablick, Meinhard, Germany
Phone
+49 (0)5651 320 512
PRRC contact
Ulrich Östreicher
EUDAMED SRN
DE-MF-000014213