BEUDAMED
    EU Manufacturer 🇫🇮 Finland Active

    Labsystems Diagnostics Oy

    SRN: FI-MF-000018281 · Tiilitie 3, FI-01720 Vantaa, Finland
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    Basic UDI-DIs
    74
    Total Devices
    75
    On Market
    75
    Off Market
    0
    Certificates
    3
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Tiilitie 3, FI-01720 Vantaa, Finland
    Email
    [email protected]
    Phone
    +358 20 155 7530
    Website
    https://www.labsystemsdx.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 69
    Eu Ivdr 5
    Classification
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    Eu Ivd General 50
    Eu Ivd Annex 2 List B 17
    Eu Ivd Class A 5
    Eu Ivd Self Testing 2
    Device Types
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    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    3
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex III Section 6 C-02-1172-802-22 May 25, 2025
    IVDD Annex III Section 6 C-02-1172-804-22 May 25, 2025
    IVDD Annex IV (excluding sections 4, 6) C-02-1172-794-22 May 26, 2025

    Market Presence

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

    🇫🇮 Finland

    Device Portfolio

    Name
    Biocard Chlamydia pneumoniae IgM
    Biocard Helicobacter pylori IgG
    Biocard Mycoplasma pneumoniae IgM
    Biocard™ Celiac Home
    Biocard™ H pylori IgG Home
    Biocard™ Helicobacter pylori Urease
    Blocard ™ Celiac Test
    COVID-19 Real Time Multiplex RT-PCR Kit
    COVID-19 Real Time Multiplex RT-PCR Kit
    Chlamydia pneumoniae IgA EIA
    Chlamydia pneumoniae IgG EIA
    Chlamydia pneumoniae IgM EIA
    Chlamydia trachomatis IgA EIA
    Chlamydia trachomatis IgG EIA
    MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.
    MYCOPLASMA PNEUMONIAE IgA EIA
    MYCOPLASMA PNEUMONIAE IgG EIA
    Mycoplasma pneumoniae IgM EIA
    NEOMASS AAAC PLUS
    NS Reader
    NS Washer
    NS2400
    NS496 Plus
    NS96 Disc Remover
    NS96 Disc Remover
    NeoMass AAAC Plus Eluent Solution
    NeoMass AAAC 3.0
    NeoMass AAAC Plus Extraction Solution B
    NeoMass AAAC Plus Internal Standard - Labelled Argininosuccinic Acid (ISTD - ASA)
    NeoMass AAAC Plus Internal Standard - Labelled Succinylacetone (ISTD - SUAC)
    NeoMass AAAC Plus Internal standard - Labelled Acylcarnitines (ISTD - AC)
    NeoMass AAAC Plus Internal standard – Labelled Amino Acids (ISTD – AA)
    NeoMass AAAC Plus dried blood spot (DBS) controls
    NeoMass CAH
    NeoMass CAH Extraction Solution with Internal Standard
    NeoMass CAH Mobile Phase A
    NeoMass CAH Mobile Phase B
    NeoMass CAH Multilevel Calibrators, Dried Blood Spot Calibrators Level 0-7
    NeoMass CAH Multilevel Controls, Dried Blood Spot Controls Level 1-3
    NeoMass CAH Reconstitution Solution
    NeoMass CAH Rinsing Solution
    NeoMass CAH System Suitability Mixture (lyophilized)
    NeoMass CAH Tuning Mixture (lyophilized)
    NeoNat SCID Real-Time PCR Kit
    NeoNat SCID Real-Time PCR Kit
    NeoNat SCID Real-Time PCR Kit
    NeoNat SCID-SMA Multiplex Real-Time PCR Kit
    NeoNat SCID-SMA Multiplex Real-Time PCR Kit
    NeoNat SCID-SMA Multiplex Real-Time PCR Kit
    NeoNat SCID-SMA Real-Time PCR Kit
    View all 75 devices →