BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    URIGHT Hemoglobin A1c Analyzer

    DI: 04713106028187 · Model: TD-4611 · TAIDOC TECHNOLOGY CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    URIGHT Hemoglobin A1c Analyzer
    Primary DI
    04713106028187
    Version / Model
    TD-4611
    Company Name
    TAIDOC TECHNOLOGY CORPORATION
    Labeler DUNS
    658530993
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-26
    Public Version
    1
    Public Version Date
    2025-04-03
    Public Version Status
    New
    Public Device Record Key
    d3f9f6f7-3d98-4c31-a89b-dac1cebe59cd

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
    LCP Assay, Glycosylated Hemoglobin

    GMDN Terms

    Code Name
    35968 Glycated haemoglobin (HbA1C) analyser IVD

    Identifiers

    Type ID
    Primary 04713106028187

    Premarket Submissions

    Submission Number Supplement Number
    K142664 000