BEUDAMED
    EU Manufacturer 🇦🇺 Australia Active

    AusDiagnostics Pty Ltd

    SRN: AU-MF-000020558 · Coward Street 290-292, 2020 Mascot, Australia
    View on EUDAMED
    Basic UDI-DIs
    88
    Total Devices
    103
    On Market
    103
    Off Market
    0
    Certificates
    4
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Coward Street 290-292, 2020 Mascot, Australia
    Email
    [email protected]
    Phone
    +61296988030
    Website
    www.ausdiagnostics.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 82
    Eu Ivdr 6
    Classification
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    Eu Ivd General 55
    Eu Ivd Annex 2 List B 27
    Eu Ivd Class A 6
    Device Types
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    Certificate Health

    Total
    4
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    4
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) V1 003496 0007 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) V1 003496 007 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) V1 003469 0007 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) V1 0034960007 May 26, 2025

    Market Presence

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

    🇮🇹 Italy

    Device Portfolio

    Name
    CRE Reference 24-well
    Respiratory Pathogens C 16-well
    Respiratory Pathogens C 16-well
    Atypical Pneumonia 8-well
    CRE 16-well
    CRE 16-well
    CRE EU 16-well
    CRE EU 16-well
    CRE Reference 24-well
    CSF 16-well
    CSF 16-well
    Demi DNA Reagent Cassette
    Demi RNA Reagent Cassette
    Dermatophytes and other Fungi 12-well
    Dermatophytes and other Fungi 12-well
    Enteric Viruses 8-well
    Enteric Viruses 8-well
    Extraction Control
    Faecal Bacteria and Parasites 12-well
    Faecal Bacteria and Parasites 12-well
    Faecal Pathogens A 16-well
    Faecal Pathogens A 16-well
    Faecal Pathogens B 16-well
    Faecal Pathogens B 16-well
    Faecal Pathogens M 16-well
    Faecal Pathogens M 16-well
    Haemochromatosis 8-well
    Haemochromatosis 8-well
    High Risk HPV Genotyping 8-well
    High Risk HPV Genotyping 8-well
    HighPlex Ascend System
    HighPlex System
    Low DNA Reagent Cassette
    Low DNA Reagent Reservoir (4 pack)
    Low RNA Reagent Cassette
    Low RNA Reagent Reservoir (4 pack)
    MT-Prep 24 System
    MT-Prep Blood DNA Extraction kit 1200 (48 samples)
    MT-Prep Viral/Pathogen Nucleic Acids Extraction kit B (48 samples)
    MT-Prep XL System
    MULTICONSTITUENT CONTROLS - INF.IMM.
    MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
    MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
    Medium DNA Reagent Reservoir (4 pack)
    Medium RNA Reagent Reservoir (4 pack)
    Parasites 8-well
    Parasites 8-well
    Prepyx® Tissue Digestion Buffer
    Puryx Comprehensive DNA / RNA Extraction Kit
    RIDA®Jump System
    View all 103 devices →