BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Microtek Medical B.V.

    Reg #: 3006116468 · FEI: 3006116468 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    39
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Microtek Medical B.V.
    Registration Number
    3006116468
    FEI Number
    3006116468
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HEKKEHORST 24
    City
    Zutphen Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K921695

    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
    Transducer, Ultrasonic, Diagnostic ITX
    Drape, Surgical, Exempt PUI
    Transducer, Ultrasonic JOP
    Bedding, Disposable, Medical KME
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Parker 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 Rolled Probe Cover Phillips 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 MTP Extraction Bag

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)