BEUDAMED
    EU Manufacturer 🇨🇳 China Active

    Sejoy Biomedical Co., Ltd.

    SRN: CN-MF-000008447 · Wuzhou Road Area C, Building 2, No.365, 311100 Hangzhou City, China
    View on EUDAMED
    Basic UDI-DIs
    64
    Total Devices
    64
    On Market
    64
    Off Market
    0
    Certificates
    4
    Valid
    0
    Expiring < 6mo
    0
    Countries
    3

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    Basic Information

    Address
    Wuzhou Road Area C, Building 2, No.365, 311100 Hangzhou City, China
    Email
    [email protected]
    Website
    www.sejoy.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 64
    Classification
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    Eu Ivd General 45
    Eu Ivd Self Testing 12
    Eu Ivd Annex 2 List B 7
    Device Types
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    Certificate Health

    Total
    4
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    3
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) No.V1 095295 0002 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) V1 095295 0002 May 26, 2025
    IVDD Annex III Section 6 1434-IVDD-265/2022 May 27, 2025
    IVDD Annex IV (excluding sections 4, 6) HL 60149972 0001 Dec 31, 2027

    Market Presence

    Devices from this manufacturer are available in 3 countries across Europe.

    🇩🇪 Germany 🇭🇷 Croatia 🇷🇴 Romania

    Device Portfolio

    Name
    Adenovirus Rapid Test (Feces)
    BLOOD GLUCOSE METERS
    Blood Glucose Monitoring system
    Dengue IgG/IgM Rapid Test Device
    Dengue IgG／IgM／NS1 Combo Rapid Test
    Dengue NS1 Antigen Rapid Test
    Digital Fertility Testing System
    FOB Rapid Test （Feces）
    FSH One Step Menopause Test
    H.pylori Antibody Rapid Test
    Hemoglobin Monitoring control solution
    Hemoglobin Monitoring meter
    Hemoglobin Test Strip
    Influenza A+B Rapid Test
    LH One Step Ovulation Test
    LH One Step Ovulation Test
    Lipid Panel Monitoring System
    MCT One Step Methcathinone Test (Urine)
    Malaria P.f ＆P.v Rapid Test (Whole Blood)
    Malaria P.f ＆Pan Rapid Test (whole blood)
    Malaria Plasmodium Falciparum Rapid Test (whole blood)
    Multi-drug Rapid Test (Urine)
    One Step Amphetamine Rapid Test (Urine)
    One Step Barbiturates Rapid Test (Urine)
    One Step Benzodiazepines Rapid Test (Urine)
    One Step Buprenorphine Rapid Test (Urine)
    One Step Cocaine Rapid Test (Urine)
    One Step Ethylenediamine-dimethylphosphinic Rapid Test (Urine)
    One Step Fentanyl Rapid Test (Urine)
    One Step Ketamine Rapid Test (Urine)
    One Step Marijuana Rapid Test (Urine)
    One Step Methadone Rapid Test (Urine)
    One Step Methamphetamine Rapid Test (Urine)
    One Step Methylenedioxymethamphetamine Rapid Test (Urine)
    One Step Morphine Rapid Test (Urine)
    One Step Opiate Rapid Test (Urine)
    One Step Oxycodone Rapid Test (Urine)
    One Step Phencyclidine Rapid Test (Urine)
    One Step Propoxyphene Test (Urine)
    One Step Tramadol Rapid Test (Urine)
    One Step Tricyclic Antidepressants Rapid Test
    PGB One Step Pregabalin Test (Urine)
    SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test
    SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit
    SARS-CoV-2 Antigen Rapid Test Cassette
    SEJOY Blood Glucose Monitoring System
    SEJOY Blood Glucose Monitoring System
    SEJOY Blood Glucose Test Strips
    SEJOY Blood Glusose Monitoring system
    Sejoy
    View all 64 devices →