BEUDAMED
    FDA Registration Active 🇵🇪 Peru

    BIOGENOMICS S.A.C. - BIOCELLS SURGICAL

    Reg #: 3021393544 · FEI: 3021393544 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    32

    Registration Details

    Registration Name
    BIOGENOMICS S.A.C. - BIOCELLS SURGICAL
    Registration Number
    3021393544
    FEI Number
    3021393544
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AV. GUARDIA CIVIL 1321, OFFICE 1303
    City
    Lima
    Country
    PE

    Regulatory Submissions

    510(k) Number
    K080560

    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
    Camera, Television, Surgical, Without Audio FWB
    Arthroscope HRX
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Instrument, Special Lens, For Endoscope FEI
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Syringe, Piston FMF
    Washer, Bolt Nut HTN
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Camera, Surgical And Accessories KQM
    Laparoscope, General & Plastic Surgery GCJ
    Accessories, Arthroscopic NBH
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Protector, Skin Pressure FMP
    Medical Device Data System OUG
    Light, Surgical, Fiberoptic FST
    Apparatus, Traction, Non-Powered HST
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    System, X-Ray, Angiographic IZI
    Bur, Surgical, General & Plastic Surgery GFF
    Orthopedic Manual Surgical Instrument LXH
    Plate, Fixation, Bone HRS
    Table And Attachments, Operating-Room BWN
    Staple, Fixation, Bone JDR
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Pin, Fixation, Smooth HTY
    Component, Traction, Non-Invasive KQZ
    Bit, Drill HTW
    Reamer HTO
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

    CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO Instrument, Special Lens, For Endoscope Blade, Saw, General & Plastic Surgery, Surgical Camera, Surgical And Accessories INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT accessories, arthroscopic Protector, Skin Pressure medical device data system Apparatus, traction, non-powered Accessories, Photographic, For Endoscope (Exclude Light Sources) bur, surgical, general & plastic surgery Orthopedic manual surgical instrument. Table And Attachments, Operating-Room COMPONENT, TRACTION, NON-INVASIVE Bit, Drill Reamer instrument, manual, surgical, general use

    Establishment Types

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