BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SCC SOFT COMPUTER

    Reg #: 1058332 · FEI: 1000307651 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SCC SOFT COMPUTER
    Registration Number
    1058332
    FEI Number
    1000307651
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5400 TECH DATA DR.
    City
    CLEARWATER
    State
    FL
    ZIP
    33760
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK040048

    Owner / Operator

    Firm Name
    SCC SOFT COMPUTER
    Operator Number
    9011704
    Address
    5400 TECH DATA DR., --
    City
    Clearwater
    State
    FL
    Postal Code
    33760
    Country
    US

    Products

    Device Name Product Code
    Blood Establishment Computer Software And Accessories MMH
    Calculator/Data Processing Module, For Clinical Use JQP

    Proprietary Names

    SoftBank II version 23.1 with DMSI SoftBank II version 25 SoftBank II version 25.1 SoftID.Tx version 1 SoftBank.web SoftBank Version 25.6.1 SoftDonor version 4.5 SoftBank II version 23.2 SoftBank Version 25.5 SoftDonor Version 4.5.5 SoftDonor.web SoftBiochemistry SoftIWS SoftID SoftTotalQC SoftGenePortal SoftPreAnalytical SoftTrack SoftGenomics SOFTMIC SOFTPATH SoftBiobank SOFTLAB SoftMolecular SoftPathDx SoftFlowCytometry SoftCytogenetics SoftHLA

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198