BEUDAMED
    EU Manufacturer 🇩🇪 Germany Active

    Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH

    SRN: DE-MF-000025295 · Altenhöferallee 3, 60438 Frankfurt am Main, Germany
    View on EUDAMED
    Basic UDI-DIs
    15
    Total Devices
    15
    On Market
    15
    Off Market
    0
    Certificates
    5
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

    Basic Information

    Address
    Altenhöferallee 3, 60438 Frankfurt am Main, Germany
    Email
    [email protected]
    Phone
    +49 (0) 69 / 400 5513 - 0
    Website
    www.gfeblut.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 10
    Eu Ivdr 5
    Classification
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    Eu Ivd General 6
    Eu Ivd Class A 5
    Eu Ivd Annex 2 List A 4
    Device Types
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    Certificate Health

    Total
    5
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    5
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) D1187700086 May 26, 2025
    IVDD Annex IV Section 4 D1187700089 May 26, 2025
    IVDD Annex IV Section 4 D1187700090 May 26, 2025
    IVDD Annex IV Section 4 D1187700088 May 26, 2025
    IVDD Annex IV Section 4 D1187700087 May 26, 2025

    Device Portfolio

    Name
    PoET B19V
    PoET Extraction
    PoET HAV
    PoET HBV
    PoET HCV
    PoET HEV
    PoET HEV Positive Control
    PoET HIV
    PoET Instrument
    PoET Internal Control
    PoET Master Positive Control
    PoET Negative Control
    PoET Prep Reagent
    PoET WNV
    PoET WNV Positive Control