BEUDAMED
    EU Manufacturer 🇦🇹 Austria Active

    GENSPEED Biotech

    SRN: AT-MF-000013008 · Gewerbepark 2, 4261 Rainbach, Austria
    View on EUDAMED
    Basic UDI-DIs
    1
    Total Devices
    1
    On Market
    1
    Off Market
    0
    Certificates
    4
    Valid
    2
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Gewerbepark 2, 4261 Rainbach, Austria
    Email
    [email protected]
    Phone
    +43 7942 20910
    Website
    www.genspeed-biotech.com

    Regulatory Overview

    Regulation
    Loading...
    Eu Ivdr 1
    Classification
    Loading...
    Eu Ivd Class B 1
    Device Types
    Loading...

    Certificate Health

    Total
    4
    Valid
    2
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
    Loading...
    Type Number Expiry Date Status
    IVDR Technical Documentation ITDA/00002/0 v002 Sep 04, 2029 Issued
    IVDR Technical Documentation ITDA/00002/0 v001 Sep 04, 2029 Withdrawn
    IVDR QMS IQMS/00002/0v001 Sep 04, 2029 Issued
    IVDR Technical Documentation ITDA/00002/0 —

    Market Presence

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

    🇦🇹 Austria

    Device Portfolio

    Name
    Vitamin D xPOC