BEUDAMED
    EU Manufacturer 🇳🇱 Netherlands Active

    Systolé Hardware B.V.

    SRN: NL-MF-000006605 · Herikerbergweg 179 179, 1101 CN Amsterdam, Netherlands
    View on EUDAMED
    Basic UDI-DIs
    1
    Total Devices
    1
    On Market
    1
    Off Market
    0
    Certificates
    1
    Valid
    0
    Expiring < 6mo
    0
    Countries
    1

    Basic Information

    Address
    Herikerbergweg 179 179, 1101 CN Amsterdam, Netherlands
    Email
    [email protected]
    Phone
    +31 88 045 06 00

    Regulatory Overview

    Regulation
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    Eu Mdd 1
    Classification
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    Eu Md Class 2a 1
    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    Expired / Withdrawn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
    MDD Annex II (excluding section 4) HD 601266800001 Sep 09, 2022

    Market Presence

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

    🇳🇱 Netherlands

    Device Portfolio

    Name
    ECG HOLTER RECORDERS