BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    PLASTIFLEX HEALTHCARE DIVISION OF PLASTIFLEX GROUP NV

    Reg #: 3008331339 · FEI: 3008331339 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    PLASTIFLEX HEALTHCARE DIVISION OF PLASTIFLEX GROUP NV
    Registration Number
    3008331339
    FEI Number
    3008331339
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Buntjesstraat 13
    City
    Paal Beringen Limburg
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K151461

    Owner / Operator

    Firm Name
    Plastiflex Healthcare Division of Plastiflex Group NV
    Operator Number
    10031967
    Address
    Buntjesstraat 13
    City
    Paal Beringen
    State
    Limburg
    Postal Code
    B-3583
    Country
    BE
    Correspondent
    Patricia DuBois

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Set, Tubing And Support, Ventilator (W Harness) BZO

    Proprietary Names

    Hybernite RT 3000 (Dual Limb), HEN12041BT1PRWGK Hybernite RT 2100 (Single Limb), HFN15023BT1SSWGK Hybernite RT 3100 (Single Limb), HFN12025BT1PRWGK Hybernite RT 1100 (Single Limb), HFN19022BT1SSWGK Hybernite RT 1000 (Dual Limb), HEN19038BT1SSWGK Hybernite RT 2000 (Dual Limb), HEN15040BT1SSWGK Hybernite RT 114 Convenience kit HFN19022BT1STWGO Hybernite ROC US HHU19018WT0ECBCK Replacement Comfortline Heated Tubing HRU19018WT0033GI Comfortline Heated Tubing HHU19018WT0033CK Hybernite HBT White HRN19018WT0ECWGC

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device