BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    SHENZHEN YHLO BIOTECH CO., LTD.

    SRN: CN-MF-000001137 · Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District,Shenzhen,Guangdong, 518116, China, 518116 SHENZHEN,Guangdong, China
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    Basic UDI-DIs
    138
    Total Devices
    175
    On Market
    175
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District,Shenzhen,Guangdong, 518116, China, 518116 SHENZHEN,Guangdong, China
    Email
    [email protected]
    Phone
    +86-755-26473359
    Website
    www.szyhlo.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 92
    Eu Ivdr 46
    Classification
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    Eu Ivd General 90
    Eu Ivd Class A 21
    Eu Ivd Class B 14
    Eu Ivd Class C 11
    Eu Ivd Annex 2 List B 2
    Device Types
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    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) V1 101298 0002 May 26, 2024

    Market Presence

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

    🇩🇪 Germany

    Device Portfolio

    Name
    iFlash-PIVKA-Ⅱ
    iFlash-PIVKA-Ⅱ
    AMH Control
    ANA Control
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
    Adiponectin Control
    Anti-Cardiolipin Control
    Anti-TP Control
    Anti-TSHR Control
    Anti-β2-Glycoprotein Ⅰ Control
    Autoimmune Diabetes Multi Control
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
    Cardiolipin IgA Control
    Cardiolipin IgG Control
    Cardiolipin IgM Control
    EB EA IgM Control
    EB NA IgA Control
    EB NA IgG Control
    EB VCA IgA Control
    EB VCA IgG Control
    EB VCA IgM Control
    ENA Multi Control
    GADA Control
    GBM IgG Control
    HA Control
    View all 175 devices →