BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    MICROTEK DOMINICANA, S.A.S.

    Reg #: 8043817 · FEI: 3003094575 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    121
    Establishment Types
    3
    Classifications
    31

    Registration Details

    Registration Name
    MICROTEK DOMINICANA, S.A.S.
    Registration Number
    8043817
    FEI Number
    3003094575
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ZONA FRANCA II
    City
    LA ROMANA
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K953673

    Owner / Operator

    Firm Name
    Medline Industries, LP
    Operator Number
    1417592
    Address
    Three Lakes Drive
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    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
    Catheter, Intravascular, Diagnostic DQO
    Bandage, Elastic FQM
    Shunt, Central Nervous System And Components JXG
    Operating Room Accessories Table Tray FWZ
    Instrument, Ultrasonic Surgical LFL
    Drape, Surgical, Antimicrobial KKX
    Cover, Shoe, Operating-Room FXP
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Dress, Surgical FYE
    Airway, Oropharyngeal, Anesthesiology CAE
    Injector And Syringe, Angiographic DXT
    Bag, Bile Collecting EXF
    Bedding, Disposable, Medical KME
    Transducer, Ultrasonic JOP
    Bag, Intestine KGY
    Drape, Patient, Ophthalmic HMT
    Accessory, Surgical Apparel LYU
    Shield, Protective, Personnel KPY
    Pack, Hot Or Cold, Water Circulating ILO
    Gown, Surgical FYA
    Catheter, Intravascular, Plaque Morphology Evaluation OGZ
    Catheter, Ultrasound, Intravascular OBJ
    Drape, Surgical, Exempt PUI
    Light, Surgical, Accessories FTA
    Tape And Bandage, Adhesive KGX
    Tube, Aspirating, Flexible, Connecting BYY
    Apparatus, Autotransfusion CAC
    Accessories, Arthroscopic NBH
    Sleeve, Limb, Compressible JOW
    Urinal FNP
    Drape, Urological, Disposable EYY

    Proprietary Names

    Accessory to Hospira Device Unna Medline Elastic Bandage Unna-Z CURAD Threeflex Bandages Fourflex Medline Elastic Retention Netting CoFlex LF2 Medline Stockinette CoFlex Sure-Wrap Elastic Bandage ACCU-SORB Matrix Microtek Esmark TwoFlex Accu-Wrap Integra Medline Reusable Non-Sterile Back Surgical Table Covers 171415-O.R. KIT CSTM LEG ANKLE WRIST AND ARM STRAPS Stabilization/Positioner Kit MEDLINE Accessories, operating-room, table (kit) - FWZ Misonix Irrigation Tube Set MRI Interventions Depuy Parker, Eclipse Probe Cover LifeLiner BERMAN AIRWAYS MEDLINE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY - CAE DYNACOR AIRWAYS "Salt Airway S.A.L.T." VARIOUS SIZES DYNACOR AIRWAYS Medline Hard Guedel Airway Bayer Merit Protection Plus Disposable Underpads Medline Disposable Underpads FitRight Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads OREX MEDICAL BEDDING DISPOSABLE BEDDING CleanOp: bedding and cleaning supplies Microtek Disposable Baby Blanket Extrasorb MICROTEK DISPOSABLE BEDDING FitRight Extended Use Underpad BEDDING Ultrasorb MEDICAL GENERAL HOSPITAL ComfortGlide Drypad Rolled Probe Cover Phillips Intestine Bag Microtek Intestine Bag C.R. Bard Navarre Ocular Occluder DePuy Safety frames / lens Drape Armour Donjoy DJO LLC CryoCube Medline Gravity Cooler Medline Orbis LVL 3 Surgical Gown Medline InfraredX Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes Medline Light Handle Cover MedFix EZ Sorbaview Polar Dressing SureSite Roll Medline Bordered Gauze Gentac EZ MedFix StickRight CURAD Naturals Stickright Pinc Medline 5-in-1 connector Medline Connecting Tubing MEDLINE TUBE, ASPIRATING, FLEXIBLE, CONNECTING - BYY DYNACOR SUCTION CONNECTING TUBING Probe Cover Gel Haemonetics Vortek Remote Control Drape Venodyne PUMP Compression Limb Sleeve Stryker Ascent Medline Level 4 Surgical Gown Medline Urinal Ocudrape Lithotomy Drape Volcano

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device