BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    POLARSEAL TAPES AND CONVERSIONS

    Reg #: 3009701308 · FEI: 3009701308 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLARSEAL TAPES AND CONVERSIONS
    Registration Number
    3009701308
    FEI Number
    3009701308
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    34-36 Carlton Park Industrial Estate, Carlton
    City
    Saxmundham Suffolk
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K120976

    Owner / Operator

    Firm Name
    PolarSeal Tapes and Conversions Ltd
    Operator Number
    10041829
    Address
    PolarSeal Tapes and Conversions, Guildford Trading Estate
    City
    Farnham
    State
    Surrey
    Postal Code
    GU9 9PZ
    Country
    GB
    Correspondent
    Carrie Borton

    US Agent

    Business Name
    MedEnvoy Global Inc.
    Contact Name
    Daryl Wisdahl
    Address
    10900 Research Blvd, Ste 160C Unit #2066
    City
    Austin
    State
    TX
    ZIP
    78759
    Country
    US
    Email
    [email protected]
    Phone
    512 2560570

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)