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    EU Manufacturer 🇨🇳 China Active

    Beijing Leadman Biochemistry Co., Ltd.

    SRN: CN-MF-000020150 · No. 5 Xinghai Road, Beijing Economic-technological Development Area No. 5 Xinghai Road, 100176 Beijing, China
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    Basic UDI-DIs
    73
    Total Devices
    73
    On Market
    73
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    0

    Basic Information

    Address
    No. 5 Xinghai Road, Beijing Economic-technological Development Area No. 5 Xinghai Road, 100176 Beijing, China
    Email
    [email protected]
    Phone
    +86-10-67855500

    Regulatory Overview

    Regulation
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    Eu Ivdd 63
    Eu Ivdr 10
    Classification
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    Eu Ivd General 61
    Eu Ivd Class A 10
    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    Expired / Withdrawn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 071450 0018 May 26, 2025

    Device Portfolio

    Name
    Higher-Sensitivity C-Reactive Protein (hs-CRP)Chemiluminescence Quantitative Immunoassay Kit
    25-Hydroxyvitamin D（25OHD）Assay Kit
    Adrenocor Ticotropic Hormore（ACTH）Assay Kit
    Amino-terminal-brain Natriuretic Peptide Precursor（NT-proBNP）Assay Kit
    Anti-Mueller Hormones（AMH）Assay Kit
    C-peptide(C-P) Chemiluminescence Quantitative Immunoassay Kit
    CI 1200 Automated Chemiluminescence Immunoassay Analyzer
    CI 2000S Automated Chemiluminescence Immunoassay Analyzer
    Cancer Antigen (CA19-9) Chemiluminescence Quantitative Immunoassay Kit
    Cancer Antigen CA72-4 Assay Kit
    Cancer antigen (CA125) Chemiluminescence Quantitative Immunoassay Kit
    Cancer antigen (CA15-3) Chemiluminescence Quantitative Immunoassay Kit
    Carbohydrate Antigen CA242 Assay Kit
    Carbohydrate Antigen CA50 Assay Kit
    Carcinoembryonic antigen (CEA) Chemiluminescence Quantitative Immunoassay Kit
    Concentrated Wash Solution
    Cortisol Assay Kit
    Creatine Kinase Isozyme(CK-MB) Chemiluminescence Quantitative Immunoassay Kit
    Cystatin C Chemiluminescence Quantitative Immunoassay Kit
    Cytokeratin Fragment 19（CYFRA21-1)Assay Kit
    Estradiol (E2) Chemiluminescence Quantitative Immunoassay Kit
    Ferritin (FER) Chemiluminescence Quantitative Immunoassay Kit
    Follicle Stimulating Hormone (FSH) Chemiluminescence Quantitative Immunoassay Kit
    Free Prostate Specific Antigen Assay kit
    Free Thyroxine (FT4) Chemiluminescence Quantitative Immunoassay Kit
    Free human chorionic gonadotropin β Chemiluminescence Quantitative Immunoassay Kit
    Free triiodothyroxine (FT3) Chemiluminescence Quantitative Immunoassay Kit
    Gastrin-releasing Peptide Precursor （ProGRP）Assay Kit
    Growth hormone (GH) Chemiluminescence Quantitative Immunoassay Kit
    Heart-type Fatty Acid Binding Protein（H-FABP）Assay Kit
    High Sensitive Thyrotropin（hs-TSH）Assay Kit
    High Sensitive Troponin-I（hs-cTnI）Assay Kit
    High Sensitive Troponin-T（hs-cTnT）Assay Kit
    Human Chorionic Gonadotropin (HCG) Chemiluminescence Quantitative Immunoassay Kit
    Human Epididymal Protein 4 (HE4)Assay Kit
    Hyaluronic Acid（HA）Assay Kit
    Immunodiagnostic Products Signal Reagent
    Insulin(INS) Chemiluminescence Quantitative Immunoassay Kit
    Interleukin-6（IL-6）Assay Kit
    Laminin（LN）Assay Kit
    Luteinizing Hormone (LH) Chemiluminescence Quantitative Immunoassay Kit
    Myoglobin(MYO) Chemiluminescence Quantitative Immunoassay Kit
    N-terminal Peptide of Type Ⅲ Procollagen(PⅢNP)Assay Kit
    Neuron-specific Enolase(NSE)Assay Kit
    Osteocalcin（OC）Assay Kit
    Pepsinogen Ⅰ（PGⅠ）Assay Kit
    Pepsinogen Ⅱ（PGⅡ）Assay Kit
    Procalcitonin(PCT) Chemiluminescence Quantitative Immunoassay Kit
    Progesterone (P) Chemiluminescence Quantitative Immunoassay Kit
    Prolactin (PRL) Chemiluminescence Quantitative Immunoassay Kit
    View all 73 devices →