BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    S-Cath

    Reg #: 9617192 · FEI: 3011308139 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    MEDIPLUS LTD.
    Registration Number
    9617192
    FEI Number
    3011308139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UNIT 7 THE GATEWAY CENTRE, CORONATION RD CRESSEX BUS. PK.
    City
    HIGH WYCOMBE, BUCKS Buckinghamshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K132890

    Owner / Operator

    Firm Name
    MEDIPLUS LTD.
    Operator Number
    9041147
    Address
    UNIT 7 THE GATEWAY CENTRE, CORONATION RD. CRESSEX BUS.PK.
    City
    HIGH WYCOMBE
    State
    Buckinghamshire
    Postal Code
    HP12 3SU
    Country
    GB
    Correspondent
    EMMA GRAY

    US Agent

    Business Name
    Promedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Catheter, Suprapubic (And Accessories) KOB

    Proprietary Names

    S-Cath

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device