BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Collaborative Care Diagnostics LLC dba BioMedix

    Reg #: 2134492 · FEI: 3002619777 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Collaborative Care Diagnostics LLC dba BioMedix
    Registration Number
    2134492
    FEI Number
    3002619777
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    860 Blue Gentian Rd Ste 195
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220527

    Owner / Operator

    Firm Name
    Collaborative Care Diagnostics, LLC dba BioMedix
    Operator Number
    10044691
    Address
    860 Blue Gentian Road, Suite 195
    City
    Eagan
    State
    MN
    Postal Code
    55121
    Country
    US
    Correspondent
    John A Romans

    Products

    Device Name Product Code
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Medical Device Data System OUG

    Proprietary Names

    PADnet Xpress PADnet 2 PADnet Read

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device