BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Temperature Sensor Foley Cathether

    Reg #: 3007798534 · FEI: 3007798534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ABLEXAN CORPORATION
    Registration Number
    3007798534
    FEI Number
    3007798534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7424 Chapel Hill Road 204
    City
    Raleigh
    State
    NC
    ZIP
    27607
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063442

    Owner / Operator

    Firm Name
    Ablexan Corporation
    Operator Number
    10029775
    Address
    7424 Chapel Hill Road 204
    City
    Raleigh
    State
    NC
    Postal Code
    27607
    Country
    US
    Correspondent
    Jeff Wang

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Temperature Sensor Foley Cathether

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device