BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Jiangsu Mole Bioscience Co., LTD.

    SRN: CN-MF-000001539 · G116 Building, No.805, Jiankang Avenue, Medical New&Hi-tech District,, 225300 Taizhou, Jiangsu, China
    View on EUDAMED
    Basic UDI-DIs
    85
    Total Devices
    316
    On Market
    316
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

    Basic Information

    Address
    G116 Building, No.805, Jiankang Avenue, Medical New&Hi-tech District,, 225300 Taizhou, Jiangsu, China
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Ivdd 74
    Eu Ivdr 11
    Classification
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    Eu Ivd General 72
    Eu Ivd Class A 11
    Eu Ivd Self Testing 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    Expired / Withdrawn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 III Section 6 1434-IVDD-010/2022 May 27, 2025

    Device Portfolio

    Name
    EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus (ORFlab, E & N genes) nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    2019-Novel Coronavirus, Influenza Virus,Respiratory Syncytial Virus Nucleic Acid Test Kit
    7 Kinds of Mutation in K-Ras Gene Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
    Automated Nucleic Acid Extraction System (Mole 32M)
    Automated Nucleic Acid Extraction System (Mole 96M)
    Automated Nucleic Acid Extraction System (Mole Fast96)
    Clarithromycin, Quinolone-resistant and Non-resistant Helicobacter pylori nucleic acid amplification test kit
    Clarithromycin, Quinolone-resistant and Non-resistant Helicobacter pylori nucleic acid amplification test kit
    Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    Clostridium difficile nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    Dengue virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    Dengue virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    Disposable Collection Tubes of Virus Samples
    View all 316 devices →