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    EU Manufacturer 🇹🇼 Taiwan Active

    Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch

    SRN: TW-MF-000023414 · Sec. 1, Xintai 5th Rd. 15F., No.93, 221416 New Taipei City, Taiwan
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    Basic UDI-DIs
    12
    Total Devices
    12
    On Market
    12
    Off Market
    0
    Certificates
    0
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

    Basic Information

    Address
    Sec. 1, Xintai 5th Rd. 15F., No.93, 221416 New Taipei City, Taiwan
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 10
    Eu Ivdr 2
    Classification
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    Eu Ivd General 10
    Eu Ivd Class A 2
    Device Types
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    Certificate Health

    No certificates registered for this manufacturer.

    Device Portfolio

    Name
    VitaPCR Flu A&B Assay
    VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay
    VitaPCR Instrument
    VitaPCR RSV External Control Set
    VitaPCR SARS-CoV-2 Assay
    VitaPCR SARS-CoV-2 External Control Set
    VitaPCR SARS-CoV-2 Gen 2 Assay
    VitaPCR SARS-CoV-2 Gen 2 External Control Set
    VitaPCR Strep A
    VitaSIRO solo Instrument
    VitaSIRO solo SARS-CoV-2/Flu/RSV Assay
    VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set