BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rolko HEAD SUPPORT HDWE- FIXATION PLATE MOUNT

    Reg #: 3016661582 · FEI: 3016661582 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Rolko North America, Inc.
    Registration Number
    3016661582
    FEI Number
    3016661582
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    398 West 230th Street
    City
    Bloomfield
    State
    IA
    ZIP
    52537
    Country
    US

    Owner / Operator

    Firm Name
    Rolko North America, Inc.
    Operator Number
    10065034
    Address
    808 Karr Ave, Suite B
    City
    Bloomfield
    State
    IA
    Postal Code
    52537
    Country
    US
    Correspondent
    Jill C Brown

    Products

    Device Name Product Code
    Support, Head And Trunk, Wheelchair IMS

    Proprietary Names

    Rolko HEAD SUPPORT HDWE- FIXATION PLATE MOUNT Rolko HEAD SUPPORT HDWE- PUSH HANDLE MOUNT Rolko Head rest from PU foam, black PU-KO-3-S Rolko Head rest from PU foam, black PU-KO-2-S Rolko Headrest small conchiform Rolko Head rest from PU foam, black PU-KO-6-S Rolko X-SHAPE HEAD SUPPORT 230X146X120 Rolko Head rest from PU foam, black PU-KO-1-S Rolko Head rest from PU foam, black PU-KO-7-S Rolko X-SHAPE HEAD SUPPORT 270X180X140 Rolko Head rest from PU foam, black PU-KO-5-S Rolko HEAD SUPPORT HARDWARE WITH GOOSENECK Rolko Headrest large conchiform Rolko HEAD SUPPORT HARDWARE 3D BALL- PUSH HANDLE FIXATION 22MM Rolko HEAD SUPPORT "horse collar" 230X185X190 Rolko HEAD SUPPORT HDWE- PUSH HANDLE MOUNT- UP TO 38MM TUBE MOUNT Rolko HEAD SUPPORT HARDWARE 3D BALL- PUSH HANDLE FIXATION 25MM

    Establishment Types

    Repack or Relabel Medical Device