BEUDAMED
    89 results · 29ms · Sources: EU EUDAMED, US FDA

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    NF-light ELISA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·UmanDiagnostics 5566982418·1 device

    Evolan Pharma AB

    Manufacturer
    🇸🇪 Sweden·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Coala Life AB

    Manufacturer
    🇸🇪 Sweden·4 Basic UDI-DIs·4 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Serotonin Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    Breas Medical AB

    Manufacturer
    🇸🇪 Sweden·32 Basic UDI-DIs·74 Devices·BSI Group The Netherlands B.V.

    Flow Neuroscience AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

    Bioglan AB

    Manufacturer
    🇸🇪 Sweden·3 Basic UDI-DIs·3 Devices·BSI Group The Netherlands B.V.

    Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500

    FDA Enforcement
    Class II ·Terminated·Permobil, Ab·October 11, 2017

    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

    FDA Enforcement
    Class II ·Ongoing·Elekta Instrument AB·May 29, 2019

    RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·April 1, 2020

    RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·December 2, 2020

    Coala Heart Monitor

    Device
    EU MDD · Eu Md Class 2a ·Coala Life AB·On the market·1 country

    Flow FL-100

    Device
    EU MDD · Eu Md Class 2a ·Flow Neuroscience AB·On the market·14 countries

    Viscopaste PB7

    Device
    EU MDD · Eu Md Class 3 ·Evolan Pharma AB·On the market·13 countries

    Ichthopaste

    Device
    EU MDD · Eu Md Class 3 ·Evolan Pharma AB·On the market·10 countries

    Zalve wound healing cream

    Device
    EU MDD · Eu Md Class 3 ·Bioglan AB·On the market·4 countries

    Vivo 30/40 PC Software

    Device
    EU MDD · Eu Md Class 2b ·Breas Medical AB·On the market·21 countries

    Coala Heart Monitor

    Device
    EU MDD · Eu Md Class 2a ·Coala Life AB·On the market·1 country

    Coala Heart Monitor

    Device
    EU MDD · Eu Md Class 2a ·Coala Life AB·On the market·1 country

    Coala Heart Monitor

    Device
    EU MDD · Eu Md Class 2a ·Coala Life AB·On the market·1 country