BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    VitalScientific B.V.

    Reg #: 8030478 · FEI: 3001576181 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    VitalScientific B.V.
    Registration Number
    8030478
    FEI Number
    3001576181
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VAN RENSSELAERWEG 4
    City
    SPANKEREN Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K102647

    Owner / Operator

    Firm Name
    VitalScientific B.V.
    Operator Number
    8030479
    Address
    Van Rensselaerweg 4
    City
    Spankeren
    State
    Gelderland
    Postal Code
    6956 AV
    Country
    NL
    Correspondent
    Adriaan P Intveld

    US Agent

    Business Name
    Clinical Diagnostic Solutions, Inc
    Contact Name
    Junelle Goldson
    Address
    1800 Nw 65th Ave
    City
    Plantation
    State
    FL
    ZIP
    33313
    Country
    US
    Email
    [email protected]
    Phone
    954 7911773

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Multi-Analyte Mixture JIX
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT

    Proprietary Names

    Selectra Mach5 Microlab 300 275-001 Carbon Dioxide Electrode, 278-001 Sodium Electrode, 279-001 Potassium Electrode, 280-001 Chloride Electrode Selectra ProM Selectra ProS

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)