BEUDAMED
    FDA Registration Active 🇪🇨 Ecuador

    BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS)

    Reg #: 3021336182 · FEI: 3021336182 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    37

    Registration Details

    Registration Name
    BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS)
    Registration Number
    3021336182
    FEI Number
    3021336182
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Francisco Casanova and Portugal
    City
    Quito Pichincha
    Country
    EC

    Regulatory Submissions

    510(k) Number
    K221396

    Owner / Operator

    Firm Name
    Biocells Discoveries Internacional (Biocells)
    Operator Number
    10083835
    Address
    Francisco Casanova and Portugal
    City
    Quito
    State
    Pichincha
    Postal Code
    170504
    Country
    EC

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

    Proprietary Names

    Medical device data system Orthopedic manual surgical instrument MENISCAL CINCH INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE CAMERA, SURGICAL AND ACCESSORIES Table And Attachments, Operating-Room Camera, Television, Surgical, Without Audio BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) BUR, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE Protector, skin pressure Accessories, arthroscopic Bit, Drill Apparatus, traction, non-powered Reamer Arthrex Plates, Screws, and Staples COMPONENT, TRACTION, NON-INVASIVE BEDDING, DISPOSABLE, MEDICAL Arthrex SwiveLock Anchor INSTRUMENT, MANUAL, SURGICAL, GENERAL USE BALANCE, ANALYTICAL

    Establishment Types

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