BEUDAMED
    FDA Registration Active 🇨🇱 Chile

    MEDLINE CHILE SPA

    Reg #: 3027977504 · FEI: 3027977504 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    38

    Registration Details

    Registration Name
    MEDLINE CHILE SPA
    Registration Number
    3027977504
    FEI Number
    3027977504
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Ave. Boulevard Poniente 1313 Bodenor Flexcenter
    City
    Pudahuel Region Metropolitana
    Country
    CL

    Regulatory Submissions

    510(k) Number
    K190950

    Owner / Operator

    Firm Name
    Medline Chile SPA
    Operator Number
    10088604
    Address
    Ave. Boulevard Poniente 1313 Bodenor Flexcenter
    City
    Pudahuel
    State
    CL-NOTA
    Postal Code
    9031287
    Country
    CL
    Correspondent
    Stephanie Augsburg

    US Agent

    Business Name
    Simcon International LLC
    Contact Name
    Rosanna Lee
    Address
    1200 Townline Rd
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US
    Email
    [email protected]
    Phone
    847 9492290

    Products

    Device Name Product Code
    Gown, Surgical FYA
    Filter, Bacterial, Breathing-Circuit CAH
    Razor, Surgical LWK
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA
    Sleeve, Limb, Compressible JOW
    Dressing, Wound, Occlusive NAD
    Bandage, Cast ITG
    Device, Intravascular Catheter Securement KMK
    Neurosurgical Paddie HBA
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Mask, Surgical FXX
    Catheter, Irrigation GBX
    Dressing, Wound, Drug FRO
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Surgeon'S Gloves KGO
    Tubing, Noninvasive GAZ
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Marker, Skin FZZ
    Bedding, Disposable, Medical KME
    Non-Surgical Gown OEA
    Tape And Bandage, Adhesive KGX
    Catheter, Peritoneal GBW
    General Surgery Tray LRO
    Stapler, Skin QQS
    Dressing, Wound, Hydrophilic NAC
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter And Tip, Suction JOL
    Bandage, Elastic FQM
    Enteral Syringes With Enteral Specific Connectors PNR
    Drape, Surgical, Exempt PUI
    Needle, Suturing, Disposable GAB
    Garment, Protective, For Incontinence EYQ
    Bottle, Collection, Vacuum KDQ
    Airway, Oropharyngeal, Anesthesiology CAE
    Drape, Surgical, Antimicrobial KKX
    Wrap, Sterilization FRG

    Proprietary Names

    Medical Glove SensiCare Neoprene Disposable Bedding Non-Surgical Gown SensiCare PI Micro Incontinence Garment

    Establishment Types

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