BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DigniCap Delta

    Reg #: 3012146457 · FEI: 3012146457 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Dignitana, Inc.
    Registration Number
    3012146457
    FEI Number
    3012146457
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10925 Estate Lane, Suite W-185
    City
    Dallas
    State
    TX
    ZIP
    75238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191166

    Owner / Operator

    Firm Name
    Dignitana Inc
    Operator Number
    10050834
    Address
    10925 Estate LN, Suite W-185
    City
    Dallas
    State
    TX
    Postal Code
    75238
    Country
    US
    Correspondent
    Niklas Lindgren

    Products

    Device Name Product Code
    Scalp Cooling System PMC

    Proprietary Names

    DigniCap Delta

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility