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Andanza GmbH

Germany DE-MF-000049142 Last updated 21 Oct 2026

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Devices
78
Registries
EUDAMED
FDA recalls
0

Catalogue78

Page 1 of 2

  • Andanza Ref POS2020AB

    Class I EUDAMED Active

  • Femosoft Ref DV1150SR

    Class I EUDAMED Active

  • Premofix Ref DV1094

    Class I EUDAMED Active

  • Andanza Ref POS1010AB

    Class I EUDAMED Active

  • Premofix Ref DV1090

    Class I EUDAMED Active

  • Premofix Ref DV1054R/LAXU

    Class I EUDAMED Active

  • Berliner UFO XL Ref K1012UX

    Class I EUDAMED Active

  • Femosoft Ref DV1150SL

    Class I EUDAMED Active

  • Premofix Ref DV1037EL

    Class I EUDAMED Active

  • Femosoft Ref DV1160XS

    Class I EUDAMED Active

  • Premofix Ref DV1056R/L

    Class I EUDAMED Active

  • Premofix Ref DV1080N

    Class I EUDAMED Active

  • Premofix Ref K1094S

    Class I EUDAMED Active

  • Andanza Ref POS1020AB

    Class I EUDAMED Active

  • Berliner UFO M Ref K1010U

    Class I EUDAMED Active

  • Premofix Ref DV2050R

    Class I EUDAMED Active

  • Premofix Ref DV1054R/L

    Class I EUDAMED Active

  • Premofix Ref DV1039EL

    Class I EUDAMED Active

  • Premofix Ref DV1037ER

    Class I EUDAMED Active

  • Premofix Ref DV1014R

    Class I EUDAMED Active

  • Andanza Ref POS1030AB

    Class I EUDAMED Active

  • Premofix Ref B1011

    Class I EUDAMED Active

  • Premofix Ref DV1038L

    Class I EUDAMED Active

  • Premofix Ref B1066

    Class I EUDAMED Active

  • Premofix Ref BBK1068

    Class I EUDAMED Active

  • Premofix Ref DV1060AXE

    Class I EUDAMED Active

  • Premofix Ref DV1036R/L

    Class I EUDAMED Active

  • Premofix Ref DV1052L XL

    Class I EUDAMED Active

  • Andanza Ref POS2030AB

    Class I EUDAMED Active

  • Andanza Ref HIPL1050A

    Class I EUDAMED Active

  • Premofix Ref DV1012SL

    Class I EUDAMED Active

  • Andanza Ref HIPL1010A

    Class I EUDAMED Active

  • Premofix Ref DV1080NK

    Class I EUDAMED Active

  • Premofix Ref DV1014L

    Class I EUDAMED Active

  • Zylinder Ref K1010ZY

    Class I EUDAMED Active

  • Andanza Ref HIPL1020A

    Class I EUDAMED Active

  • Premofix Ref DV1033R XL

    Class I EUDAMED Active

  • Premofix Ref DV1039ER

    Class I EUDAMED Active

  • Premofix Ref DV1094 10

    Class I EUDAMED Active

  • Premofix Ref B1045

    Class I EUDAMED Active

  • CoolAir Poncho Custom Size Ref CAP03S

    Class I EUDAMED Active

  • Femosoft Ref DV1170ST

    Class I EUDAMED Active

  • Femosoft Ref DV1170SC

    Class I EUDAMED Active

  • Femosoft Ref DV1170SN

    Class I EUDAMED Active

  • Premofix Ref DV1079C

    Class I EUDAMED Active

  • Andanza Ref POS1040AB

    Class I EUDAMED Active

  • Premofix Ref DV1042

    Class I EUDAMED Active

  • Premofix Ref DV1092

    Class I EUDAMED Active

  • Premofix Ref DV1033L XL

    Class I EUDAMED Active

  • Premofix Ref DV1091 S

    Class I EUDAMED Active

Showing 1-50 of 78

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 GmbH makes

Andanza GmbH manufactures bandages, fast-pressure systems, and compression products designed for post-procedure aftercare of puncture sites. The Zeppelin is a pressure system for securing puncture points, while the Premofix uno R and Premofix uno L are adhesive bandages for wound and puncture site management.

All products fall under Class I medical devices and are registered in the EUDAMED database. The company is based in Germany and adheres to EU regulatory requirements for these categories.

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 GmbH manufacture?

Andanza GmbH specializes in bandages, fast-pressure systems, and compression products. These devices are specifically designed for the aftercare of puncture sites, ensuring secure wound management and pressure application post-procedure. Examples include the Zeppelin pressure system and Premofix uno R/L adhesive bandages.

Where is Andanza GmbH based, and what regulatory requirements does it follow?

Andanza GmbH is based in Germany. Since its devices fall under Class I medical devices, they must comply with EU regulatory standards, including registration in the EUDAMED database. This classification applies because these products are low-risk, non-invasive items intended for short-term use in wound and puncture site management.

Are Andanza GmbH’s devices listed in any regulatory registries?

Yes, Andanza GmbH’s devices are registered in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers list their products to ensure transparency and compliance with EU medical device regulations. This registration is mandatory for Class I devices marketed within the EU.

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

Andanza GmbH’s devices are classified as Class I medical devices. This classification is determined by their intended use—low-risk, non-invasive products like bandages and compression systems for post-procedure puncture site care. Class I devices typically require less stringent regulatory oversight than higher-risk categories but still must meet essential safety and performance requirements.

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

Information

Country
Germany
Address
12, Europaring, Meinhard, Germany
Phone
+49 5651 320 512
PRRC contact
Ulrich Östreicher
EUDAMED SRN
DE-MF-000049142