BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COFOE

    DI: 06950715500002 · Model: ZA-01 · Cofoe Medical Technology Co.,Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COFOE
    Primary DI
    06950715500002
    Version / Model
    ZA-01
    Company Name
    Cofoe Medical Technology Co.,Ltd
    Labeler DUNS
    544425204
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-10
    Public Version
    1
    Public Version Date
    2022-01-18
    Public Version Status
    New
    Public Device Record Key
    50793313-3109-4fb4-ac89-10b7ec34a7ed
    Distribution End Date
    2056-08-18

    Device Description

    Behind-the-ear hearing aid, single ear (ABS, wired charging, hearing aid size: 8.85mm*53.66mm*14.95mm)

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ESD Hearing Aid, Air Conduction

    GMDN Terms

    Code Name
    34671 Air-conduction hearing aid, behind-the-ear

    Identifiers

    Type ID
    Primary 06950715500002