BEUDAMED
    Authorized Representative 🇫🇷 France Active

    iHealthLabs Europe

    SRN: FR-AR-000000340 · Rue de Ponthieu 36, 75008 Paris, France
    View on EUDAMED
    Manufacturers
    1
    Devices
    11
    Certificates
    3
    PRRCs
    1

    Basic Information

    Address
    Rue de Ponthieu 36, 75008 Paris, France
    Email
    [email protected]
    Website
    https://ihealthlabs.eu/
    VAT Number
    FR91792514341
    EORI
    FR79251434100033

    Non-EU Manufacturers

    Name
    Andon Health Co., Ltd.

    Manufacturers

    Andon Health Co., Ltd.

    Manufacturer
    🇨🇳 China·8 Basic UDI-DIs·11 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Certificates

    Type Number
    MDR QMS HZ 2095583-1
    MDD Annex II (excluding section 4) HD 60149938 0001
    MDD Annex II (excluding section 4) HD601499380001

    Devices

    Infrared Forehead Thermometer

    Device
    EU MDD · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·6 countries

    mHealth

    Device
    EU MDR · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·32 countries

    NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS

    Device
    EU MDR · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·2 countries

    KD-5920V

    Device
    EU MDR · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·1 country

    NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS

    Device
    EU MDR · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·2 countries

    NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS

    Device
    EU MDR · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·2 countries

    TENS

    Device
    EU MDD · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·1 country

    TENS

    Device
    EU MDD · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·1 country

    Wrist Blood Pressure Monitor

    Device
    EU MDD · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·2 countries

    Arm Blood Pressure Monitor

    Device
    EU MDD · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·2 countries

    Wrist Blood Pressure Monitor

    Device
    EU MDR · Eu Md Class 2a ·Andon Health Co., Ltd.·On the market·2 countries