BEUDAMED
    EU Manufacturer 🇪🇸 Spain Active

    Blackhills Diagnostic Resources S.L.U.

    SRN: ES-MF-000001091 · Camino del Pilón 86, 50011 Zaragoza, Spain
    View on EUDAMED
    Basic UDI-DIs
    48
    Total Devices
    70
    On Market
    70
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    32

    Basic Information

    Address
    Camino del Pilón 86, 50011 Zaragoza, Spain
    Email
    [email protected]
    Website
    https://www.bdrdiagnostics.com/

    Regulatory Overview

    Regulation
    Loading...
    Eu Ivdd 28
    Eu Ivdr 20
    Classification
    Loading...
    Eu Ivd General 26
    Eu Ivd Class C 20
    Eu Ivd Annex 2 List B 2
    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    Expired / Withdrawn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) CE 588493 May 26, 2025

    Market Presence

    Devices from this manufacturer are available in 32 countries across Europe.

    🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

    Device Portfolio

    Name
    Adellgene® Myotonic Dystrophy Screening 16 tests
    Adellgene® Fragile X 100 tests
    Adellgene® Fragile X 25 tests
    Adellgene® Fragile X Screening 16 tests
    Adellgene® Fragile X Screening 48 tests
    Adellgene® Friedreich's Ataxia 16 tests
    Adellgene® Huntington Disease 16 tests
    Adellgene® Myotonic Dystrophy Confirmatory 16 tests
    Adellgene® SCAs 16 tests
    Genvinset® MTHFR C677T 96 tests
    Genvinset® FIIFV multiplex 24 test
    Genvinset® FIIFV multiplex 48 test
    Genvinset® FIIFV multiplex 96 test
    Genvinset® Factor II G20210A 24 test
    Genvinset® Factor II G20210A 48 test
    Genvinset® Factor II G20210A 96 test
    Genvinset® Factor V G1691A 24 tests
    Genvinset® Factor V G1691A 48 tests
    Genvinset® Factor V G1691A 96 tests
    Genvinset® HFE C282Y 24 tests
    Genvinset® HFE C282Y 48 tests
    Genvinset® HFE C282Y 96 tests
    Genvinset® HFE H63D 24 tests
    Genvinset® HFE H63D 48 tests
    Genvinset® HFE H63D 96 tests
    Genvinset® HFE S65C 24 tests
    Genvinset® HFE S65C 48 tests
    Genvinset® HFE S65C 96 test
    Genvinset® HFE multiplex 24 test
    Genvinset® HFE multiplex 48 test
    Genvinset® HFE multiplex 96 test
    Genvinset® HLA A29 24 tests
    Genvinset® HLA A29 48 tests
    Genvinset® HLA B27v5 24 tests
    Genvinset® HLA B27v5 48 tests
    Genvinset® HLA B57v5 24 tests
    Genvinset® HLA B57v5 48 tests
    Genvinset® HLA Behçet v5 24 tests
    Genvinset® HLA Behçet v5 48 tests
    Genvinset® HLA C*06 24 tests
    Genvinset® HLA C*06 48 tests
    Genvinset® HLA Celiac 24 tests
    Genvinset® HLA Celiac 48 tests
    Genvinset® HLA Celiac Plus 24 tests
    Genvinset® HLA Celiac Plus 48 tests
    Genvinset® HLA DQA1*05 24 tests
    Genvinset® HLA DQA1*05 48 test
    Genvinset® HLA DQB1*03:02 24 tests
    Genvinset® HLA DQB1*03:02 48 tests
    Genvinset® HLA Narcolepsy 24 tests
    View all 70 devices →