BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    FYSICON BV

    Reg #: 3010716438 · FEI: 3010716438 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    FYSICON BV
    Registration Number
    3010716438
    FEI Number
    3010716438
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hoogheuvelstraat 114
    City
    Oss Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K170032

    Owner / Operator

    Firm Name
    Fysicon BV
    Operator Number
    10047296
    Address
    Hoogheuvelstraat 14
    City
    Oss
    State
    Noord-Brabant
    Postal Code
    5349BA
    Country
    NL
    Correspondent
    Mindy McCann

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Medical Device Data System OUG

    Proprietary Names

    QMAPP Hemo #01076101 QMAPP EP #01076102 QMAPP GO #01076110 QMAPP PCM 01076100 QMAPP Hybrid # 01076106 QMAPP Connection Box # 01076094 QMAPP Hemo Lite #01076103 QMAPP #01076001 DataLinQ (DatalinQ 2 PAD, DataLinQ ATR, DataLinQ CRM as components) DataLinQ USG QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device