BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    medicalprint shell beige 2.0 1000g

    DI: EDET030161 · Model: 03016 · DETAX GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    medicalprint shell beige 2.0 1000g
    Primary DI
    EDET030161
    Version / Model
    03016
    Company Name
    DETAX GmbH
    Labeler DUNS
    343947949
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-25
    Public Version
    1
    Public Version Date
    2026-03-05
    Public Version Status
    New
    Public Device Record Key
    372b4c38-e795-4c2a-9210-9484e923854b

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ESD Hearing Aid, Air-Conduction, Prescription

    GMDN Terms

    Code Name
    41228 Earmould, custom-made

    Identifiers

    Type ID
    Primary EDET030161