BEUDAMED
    EU Manufacturer ๐Ÿ‡ง๐Ÿ‡ช Belgium Active

    D-tek s.a.

    SRN: BE-MF-000024530 ยท rue Renรฉ Descartes 19, 7000 Mons, Belgium
    View on EUDAMED
    Basic UDI-DIs
    77
    Total Devices
    77
    On Market
    77
    Off Market
    0
    Certificates
    3
    Valid
    0
    Expiring < 6mo
    0
    Countries
    19

    Basic Information

    Address
    rue Renรฉ Descartes 19, 7000 Mons, Belgium
    Email
    [email protected]
    Phone
    +3265841888
    Website
    www.d-tek.be

    Regulatory Overview

    Regulation
    Loading...
    Eu Ivdd 74
    Eu Ivdr 3
    Classification
    Loading...
    Eu Ivd General 74
    Eu Ivd Class A 3
    Device Types
    Loading...

    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    0
    Certificates by Expiry Year
    Loading...
    Type Number Expiry Date Status
    IVDD Annex III Section 6 BE24/00000082 Jun 18, 2027
    IVDD Annex III Section 6 BE24-00000082 Jun 18, 2027
    IVDD Annex III Section 6 BE/2400000082 Jun 18, 2027

    Market Presence

    Devices from this manufacturer are available in 19 countries across Europe.

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

    Device Portfolio

    Name
    BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software
    BlueDiver Dot ANA + DFS-70 IgG
    BlueDiver Dot ANA10 IgG
    BlueDiver Dot ANA12 IgG
    BlueDiver Dot ANA12 Screen IgG
    BlueDiver Dot ANA8 IgG
    BlueDiver Dot ANCA+GBM IgG
    BlueDiver Dot APS IgG
    BlueDiver Dot ASCA IgG + IgA
    BlueDiver Dot Celiac IgA
    BlueDiver Dot Celiac IgG
    BlueDiver Dot Chromatin IgG
    BlueDiver Dot Chromatin4 IgG
    BlueDiver Dot Connectivitis10 IgG
    BlueDiver Dot Cytoplasm6 IgG
    BlueDiver Dot ENA6 IgG
    BlueDiver Dot GAD IgG
    BlueDiver Dot Gastritis IgG
    BlueDiver Dot Granular12 IgG
    BlueDiver Dot Liver10 IgG
    BlueDiver Dot Liver5 IgG
    BlueDiver Dot Liver7 IgG
    BlueDiver Dot Milk Intolerance IgG
    BlueDiver Dot Mitochondria2 IgG + IgM
    BlueDiver Dot Myositis12 SAE IgG
    BlueDiver Dot PRL12 IgG
    BlueDiver Dot Polymyositis/Scleroderma12 IgG
    BlueDiver Dot Polymyositis/Scleroderma8 IgG
    BlueDiver Dot Scleroderma10 IgG
    BlueDiver Dot Scleroderma12 IgG
    BlueDiver Dot Synthetase10 IgG
    BlueDiver Instrument
    BlueDiver Instrument 2
    BlueDiver Quantrix ANA19 IgG
    BlueDiver Quantrix ANA25 Screen IgG
    BlueDiver Quantrix Liver10 IgG
    BlueDot ANA + DFS-70 IgG
    BlueDot ANA10 IgG
    BlueDot ANA12 IgG
    BlueDot ANA12 Screen IgG
    BlueDot ANA8 IgG
    BlueDot ANCA+GBM IgG
    BlueDot APS IgG
    BlueDot ASCA IgG + IgA
    BlueDot Celiac IgA
    BlueDot Celiac IgG
    BlueDot Chromatin IgG
    BlueDot Chromatin4 IgG
    BlueDot Connectivitis 10 IgG
    BlueDot Cytoplasm6 IgG
    View all 77 devices โ†’