BEUDAMED
    EU Manufacturer 🇩🇪 Germany Active

    BIOEUROPE GmbH

    SRN: DE-MF-000039230 · Europaplatz 1, 88131 Lindau, Germany
    View on EUDAMED
    Basic UDI-DIs
    18
    Total Devices
    18
    On Market
    18
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Europaplatz 1, 88131 Lindau, Germany
    Email
    [email protected]
    Phone
    +49 8382 947979 0
    Website
    www.bioeuropegmbh.com

    Regulatory Overview

    Regulation
    Loading...
    Eu Ivdd 17
    Eu Ivdr 1
    Classification
    Loading...
    Eu Ivd General 12
    Eu Ivd Self Testing 4
    Eu Ivd Class B 1
    Eu Ivd Annex 2 List B 1
    Device Types
    Loading...

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
    Loading...
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) 22823 May 26, 2025

    Market Presence

    Devices from this manufacturer are available in 1 country across Europe.

    🇩🇪 Germany

    Device Portfolio

    Name
    Bioeurope 14 Food Intolerance Test (ref:7182)
    Bioeurope 14 Food Intolerance Test (ref:7194)
    Bioeurope 4 Food Intolerance Test (ref:7184)
    Bioeurope 4 Food Intolerance Test (ref:7187)
    Bioeurope 42 Food Intolerance Test (ref:7179)
    Bioeurope 7 Food Intolerance Test (ref:7181)
    Bioeurope 7 Food Intolerance Test (ref:7189)
    Bioeurope 90 Food Intolernace Test (ref:7180)
    EZ-Microalbumin Screening Test
    Fortel Kidney Disease (Microalbumin) Screening Test
    Fortel Prostate (PSA) Screening Test
    Fortel Ulcer (H. pylori) Screening Test
    Fortel Ultra Sensitive Pregnancy Midstream 1-Test
    Fortel Ultra Sensitive Pregnancy Midstream 1-Test
    Isletest GAD ELISA
    Isletest IAA ELISA
    Isletest ICA ELISA
    NutriDetect 90G B ELISA