BEUDAMED
    FDA Registration Active 🇵🇪 Peru

    BIOGENOMICS S.A.C. - BIOCELLS SURGICAL

    Reg #: 3021393544 · FEI: 3021393544 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BIOGENOMICS S.A.C. - BIOCELLS SURGICAL
    Registration Number
    3021393544
    FEI Number
    3021393544
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AV. GUARDIA CIVIL 1321, OFFICE 1303
    City
    Lima
    Country
    PE

    Regulatory Submissions

    510(k) Number
    K062466

    Owner / Operator

    Firm Name
    Biogenomics S.A.C. - Biocells Surgical
    Operator Number
    10084035
    Address
    AV. GUARDIA CIVIL 1321, OFFICE 1303
    City
    Lima
    State
    PE-LMA
    Postal Code
    15036
    Country
    PE

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device