BEUDAMED
    EU Manufacturer ๐Ÿ‡จ๐Ÿ‡ณ China Active

    Beijing Hotgen Biotech Co., Ltd.

    SRN: CN-MF-000015566 ยท 6th, 7th and 9th Buildings, No. 55 Qingfeng West Road, Daxing District, 102629, Beijing, PEOPLE'S REPUBLIC OF CHINA., 102629 Beijing, China
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    Basic UDI-DIs
    80
    Total Devices
    81
    On Market
    81
    Off Market
    0
    Certificates
    0
    Valid
    0
    Expiring < 6mo
    0
    Countries
    2

    Basic Information

    Address
    6th, 7th and 9th Buildings, No. 55 Qingfeng West Road, Daxing District, 102629, Beijing, PEOPLE'S REPUBLIC OF CHINA., 102629 Beijing, China
    Email
    [email protected]
    Phone
    +86 400-815-1117

    Regulatory Overview

    Regulation
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    Eu Ivdr 80
    Classification
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    Eu Ivd Class B 44
    Eu Ivd Class C 34
    Eu Ivd Class A 2
    Device Types
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    Certificate Health

    No certificates registered for this manufacturer.

    Market Presence

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

    ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฎ๐Ÿ‡น Italy

    Device Portfolio

    Name
    25-hydroxy-vitamin D test (Chemiluminescence Immunoassay)
    25-hydroxy-vitamin D test (Up-converting Phosphor Technology)
    25-hydroxy-vitamin D test (Up-converting Phosphor Technology)
    Anti-Cyclic Citrullinated Peptide Antibody test (Chemiluminescence Immunoassay)
    Anti-Glutamic Acid Decarboxylase Antibody test (Chemiluminescence Immunoassay)
    Anti-Insulin Antibody test (Chemiluminescence Immunoassay)
    Anti-Islet Cell Antibody test (Chemiluminescence Immunoassay)
    Anti-Mullerian Hormone Test (Up-converting Phosphor Technology)
    Anti-Mullerian hormone test (Chemiluminescence Immunoassay)
    Anti-Tyrosine Phosphatase Antibodies test (Chemiluminescence Immunoassay)
    Anti-cyclic Citrullinated Peptide Antibody Test ((Enzyme-Linked Immunosorbent Assay)
    Anti-cyclic Citrullinated Peptide Antibody rapid test (Colloidal Gold)
    Anti-thyroglobulin Antibody test (Chemiluminescence Immunoassay)
    Antibody to thyroid peroxidase test (Chemiluminescence Immunoassay)
    Automatic Chemiluminescence Immunoassay Analyzer
    B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)
    C reactive protein test (Up-converting Phosphor Technology)
    C-Peptide test (Up-converting Phosphor Technology)
    C-reactive protein test (Chemiluminescence Immunoassay)
    Cancer Antigen 125 test (Chemiluminescence Immunoassay)
    Cancer Antigen 15-3 test (Chemiluminescence Immunoassay)
    Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)
    Cancer Antigen 242 test (Chemiluminescence Immunoassay)
    Cancer Antigen 72-4 test (Chemiluminescence Immunoassay)
    Carcinoembryonic Antigen test (Chemiluminescence Immunoassay)
    Cardiac Troponin I / Creatine Kinase Isozyme MB/ Myoglobin combination test (Up-converting Phosphor Technology)
    Cardiac Troponin I /N-terminal Pro-B-type Natriuretic Peptide combination test (Up-converting Phosphor Technology)
    Cardiac Troponin-I test (Up-converting Phosphor Technology)
    Creatine kinase mb test (Chemiluminescence Immunoassay)
    Cytokeratin 19 Fragments test (Chemiluminescence Immunoassay)
    D-Dimer test (Chemiluminescence Immunoassay)
    Estradiol test (Chemiluminescence Immunoassay)
    Ferr/FA/VB12/25-OH-VD Quality Control
    Folate test (Chemiluminescence Immunoassay)
    Follicle-stimulating Hormone test (Chemiluminescence Immunoassay)
    Free Thyroxine test (Chemiluminescence Immunoassay)
    Free Thyroxine test (Up-converting Phosphor Technology)
    Free Triiodothyronine test (Chemiluminescence Immunoassay)
    Free Triiodothyronine test (Up-converting Phosphor Technology)
    Gastrin Releasing Peptide Precursor test (Chemiluminescence Immunoassay)
    Gastrin-17 test (Chemiluminescence Immunoassay)
    Glycosylated Hemoglobin test (Chemiluminescence Immunoassay)
    Glycosylated hemoglobin test (Up-converting Phosphor Technology)
    Growth Hormone test (Chemiluminescence Immunoassay)
    High Sensitive Troponin T test (Chemiluminescence Immunoassay)
    High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)
    Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)
    Insulin test (Up-converting Phosphor Technology)
    Insulin-like Growth Factor Binding Protein-3 test (Chemiluminescence Immunoassay)
    Interleukin-6 test (Chemiluminescence Immunoassay)
    View all 81 devices โ†’