BEUDAMED
    EU Manufacturer 🇨🇳 China

    Hangzhou Realy Tech Co.,Ltd.

    SRN: CN-MF-000004716 · #2 Building, No. 763, Yuansha Village, Xinjie Street, Xiaoshan District, 311200 Hangzhou，Zhejiang, China
    View on EUDAMED
    Basic UDI-DIs
    128
    Total Devices
    129
    On Market
    129
    Off Market
    0
    Certificates
    3
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    #2 Building, No. 763, Yuansha Village, Xinjie Street, Xiaoshan District, 311200 Hangzhou，Zhejiang, China
    Email
    [email protected]
    Phone
    +86-571-5605 0794
    Website
    www.realytech.com

    Regulatory Overview

    Regulation
    Loading...
    Eu Ivdd 126
    Eu Ivdr 2
    Classification
    Loading...
    Eu Ivd General 123
    Eu Ivd Self Testing 3
    Eu Ivd Class A 2
    Device Types
    Loading...

    Certificate Health

    Total
    3
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    3
    Certificates by Expiry Year
    Loading...
    Type Number Expiry Date Status
    IVDD Annex III Section 6 CeCert/100/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/025/W/E.1 May 26, 2025
    IVDD Annex III Section 6 CeCert/036/W/E.1 May 26, 2025

    Market Presence

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

    🇩🇪 Germany

    Device Portfolio

    Name
    Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)
    2-IN-1 COVID-19 Antigen Rapid Test Device (swab)
    2-IN-1 COVID-19 Antigen Rapid Test Device（Nasal&Saliva）
    2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma)
    2019-nCOV-IgM Assay Reagent Kit (CMIA)
    2019-nCoV-IgG Assay Reagent Kit (CMIA)
    Adrenocorticotropic Hormone (ACTH) Assay Reagent Kit (CMIA)
    Alpha-fetoprotein (AFP) Assay Reagent Kit (CMIA)
    Amphetamine (AMP) Assay Reagent Kit (CMIA)
    Anti-Cyclic Citrullinated Peptide (Anti-CCP) Assay Reagent Kit(CMIA)
    Anti-Thyroglobulin (Anti-Tg) Assay Reagent Kit (CMIA)
    Anti-Thyroid Peroxidase (Anti-TPO) Assay Reagent Kit (CMIA)
    Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA)
    Benzodiazepine (BZO) Assay Reagent Kit (CMIA)
    Beta-2 Microglobulin (β2-MG) Assay Reagent Kit (CMIA)
    Buprenorph (BUP) Assay Reagent Kit (CMIA)
    C-peptide(CP) Assay Reagent Kit(CMIA)
    C-reactive Protein Rapid Test Device(Colloidal Gold)
    CORONAVIRUS [obsolete from 2025-01-01]
    CYFRA 21-1 Assay Reagent Kit (CMIA)
    Carbohydrate Antigen 125 (CA125) Assay Reagent Kit (CMIA)
    Carbohydrate Antigen 15-3 (CA15-3) Assay Reagent Kit (CMIA)
    Carbohydrate Antigen 19-9(CA19-9) Assay Reagent Kit(CMIA)
    Carbohydrate antigen 242 Assay Reagent Kit (CMIA)
    Carbohydrate antigen 50 Assay Reagent Kit (CMIA)
    Carbohydrate antigen 72-4 Assay Reagent Kit (CMIA)
    Carcinoembryonic Antigen (CEA) Assay Reagent Kit (CMIA)
    Cardiac Troponin I Rapid Test Device(Colloidal Gold)
    Cocaine（COC）Assay Reagent Kit (CMIA)
    Cortisol (Cor) Assay Reagent Kit (CMIA)
    D-Dimer Rapid Test Device (Colloidal Gold)
    D-Dimer Rapid Test Device (Colloidal Gold)
    Dehydroepiandrosterone Sulfate (DHEA-S) Assay Reagent Kit (CMIA)
    FSH Rapid Test Device
    Folate Assay Reagent Kit (CMIA)
    Free Beta-Human Chorionic Gonadotropin (Free β-HCG) Assay Reagent Kit (CMIA)
    Free T3 (FT3) Assay Reagent Kit (CMIA)
    Free T4 (FT4) Assay Reagent Kit (CMIA)
    HPV IgM Rapid Test Device
    HbA1C Rapid Test Strip (Colloidal Gold)
    HbA1c Assay Reagent Kit (CMIA)
    Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA)
    Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA)
    Herpes Simplex Virus -Ⅰ/Ⅱ IgG (HSV-Ⅰ/Ⅱ IgG) Assay Reagent Kit (CMIA)
    Herpes Simplex Virus -Ⅰ/Ⅱ IgM (HSV-Ⅰ/Ⅱ IgM) Assay Reagent Kit (CMIA)
    Herpes Simplex Virus -Ⅱ IgM (HSV-Ⅱ IgM) Assay Reagent Kit (CMIA)
    Herpes Simplex Virus-Ⅱ IgG(HSV-Ⅱ IgG) Assay Reagent Kit(CMIA)
    Human Chorionic Gonadotropin (HCG) Assay Reagent Kit (CMIA)
    Human Epidermal GrowthFactor Receptor 2（HER-2）Assay Reagent Kit (CMIA)
    Human Epididymis Protein 4 (HE4) Assay Reagent Kit (CMIA)
    View all 129 devices →