BEUDAMED
    EU Manufacturer πŸ‡¨πŸ‡³ China Active

    Shenzhen Zijian Biotechnology Co., Ltd

    SRN: CN-MF-000022829 Β· 502, Building A, Qiaode Science Park, No.7, Guangming Hi-tech Park West, Tianliao Community, Yutang Street, 518107 Shenzhen, China
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    Basic UDI-DIs
    287
    Total Devices
    368
    On Market
    368
    Off Market
    0
    Certificates
    2
    Valid
    1
    Expiring < 6mo
    0
    Countries
    2

    Basic Information

    Address
    502, Building A, Qiaode Science Park, No.7, Guangming Hi-tech Park West, Tianliao Community, Yutang Street, 518107 Shenzhen, China
    Email
    [email protected]
    Phone
    +86-755-26614284
    Website
    http://www.szzijian.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 279
    Eu Ivdr 7
    Eu Mdr 1
    Classification
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    Eu Ivd General 279
    Eu Ivd Class A 7
    Eu Md Class 1 1
    Device Types
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    Certificate Health

    Total
    2
    Valid
    1
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex III Section 6 CeCert/086/W/E.1 May 26, 2025
    MDR QA CN23/00006997 Dec 22, 2028 Issued

    Market Presence

    Devices from this manufacturer are available in 2 countries across Europe.

    πŸ‡ͺπŸ‡Έ Spain πŸ‡³πŸ‡± Netherlands

    Device Portfolio

    Name
    15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing)
    17Ξ±-Hydroxyprogesterone Detection Kit(CLIA)
    2019-nCoV Nucleic acid Detection Kit (Real Time PCR)
    AFP FIA Kit
    ANA Screen FIA Kit
    AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
    AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
    Activated type:25pcs/kit V 20-10-25
    Adenovirus FIA Kit
    Adenovirus IgM Detection Kit(CLIA)
    Adrendcorticotrophic Hormone(ACTH)Detection Kit(CLIA)
    Aldosterone(ALD) Detection Kit(CLIA)
    Angio-I(A I) Detection Kit(CLIA)
    Angio-II(A II) Detection Kit(CLIA
    Anti-CCP FIA Kit
    Anti-TPO FIA Kit
    Anti-Thyroid Peroxidase (Anti-TPO) Detection Kit(CLIA)
    Anti-mullerian hormone (AMH ) Detection Kit(CLIA)
    Anti-mullerian hormone (AMH) Detection Kit(Fluorescence Immunoassay)
    Anti-tyrosine Phosphatase 2 antibody(Anti-IA2-IgG) Detection Kit(CLIA)
    Automatic Nucleic Acid Extractor
    Automatic Nucleic Acid Extractor
    Beta Subunit of Human Chorionic Gonadotropin (Ξ²-HCG) Detection Kit(Fluorescence Immunoassay)
    C-Reactive Protein (CRP) Detection Kit(CLIA)
    C-peptide (C-P) Detection Kit(CLIA)
    C-peptide FIA Kit
    CA125 FIA Kit
    CA15-3 FIA Kit
    CA19-9 FIA Kit
    CA72-4 FIA Kit
    CEA FIA Kit
    CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
    Calcitonin(CT)Detection Kit(CLIA)
    Calprotectin FIA Kit
    Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay)
    Cardiac Troponin I(cTnI)Detection Kit(CLIA)
    Cortisol Detection Kit(CLIA)
    Coxsackie virus group A type 16 & enterovirus type 71 Diagnostic Kit (PCR-Fluorescence Probing)
    Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing)
    Creatine Kinase Isoenzyme (CK-MB) Detection Kit(CLIA)
    Creatine Kinase Isoenzyme (CK-MB) Detection Kit(Fluorescence Immunoassay)
    Cys-C FIA Kit
    D-Dimer Detection Kit(CLIA)
    D-dimer Detection Kit(Fluorescence Immunoassay)
    DHEA-S FIA Kit
    DS-DNA FIA Kit
    Dehydroepiandrosterone and its sulfate (DHEA-S) Detection Kit(CLIA)
    Dengue IgG/IgM FIA Kit
    Dengue NS1 Ag FIA Kit
    Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)
    View all 368 devices β†’