BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENTEROTRACK

    Reg #: 3015545064 · FEI: 3015545064 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ENTEROTRACK
    Registration Number
    3015545064
    FEI Number
    3015545064
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1200 Diamond Cir Ste B
    City
    Lafayette
    State
    CO
    ZIP
    80026
    Country
    US

    Owner / Operator

    Firm Name
    EnteroTrack
    Operator Number
    10060542
    Address
    12635 E. Montview Blvd, Suite 139
    City
    Aurora
    State
    CO
    Postal Code
    80045
    Country
    US
    Correspondent
    Robin Shandas

    Products

    Device Name Product Code
    Container, Specimen, Non-Sterile NNI
    Container, Specimen, Sterile FMH

    Establishment Types

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