BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ACRYFREE BIOSENS FLEXINYLON

    Reg #: 3011532731 · FEI: 3011532731 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PERFLEX LTD
    Registration Number
    3011532731
    FEI Number
    3011532731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 Giborey Israel St. Beit Adar entry D 1, New Industrial Area Ramat Poleg
    City
    Netanya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K150454

    Owner / Operator

    Firm Name
    Perflex Ltd
    Operator Number
    10048177
    Address
    7 Giborey Israel St. Beit Adar entry D 1, New Industrial Area Ramat Poleg
    City
    Netanya
    State
    IL-NOTA
    Postal Code
    4250407
    Country
    IL
    Correspondent
    Mrs. Perla Ben-Simon

    US Agent

    Business Name
    Medes USA C/O Matan Arazy
    Contact Name
    Benny Arazy
    Address
    15201 6th Ave NE, ,
    City
    Shoreline
    State
    WA
    ZIP
    98155
    Country
    US
    Email
    [email protected]
    Phone
    415 9921126

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Mouthguard, Prescription MQC

    Proprietary Names

    ACRYFREE BIOSENS FLEXINYLON T-Crystal

    Establishment Types

    Manufacture Medical Device