BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    InfoVAC with Gel, 10 Pack

    Reg #: 3004681519 · FEI: 3003870583 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Belgium Fleurus SA
    Registration Number
    3004681519
    FEI Number
    3003870583
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zoning Industrial de Fleurus, Avenue De L Esperance, 17
    City
    Fleurus Hainaut
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K063740

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    InfoVAC with Gel, 10 Pack InfoVAC without Gel, 10 Pack Granufoam Medium Dressing, 5 Pack Granufoam Medium Dressing, 10 Pack INFOVAC CAN ASSY, W/O GEL, 10 PK INFOVAC CAN ASSY, W/O GEL, 5 PK INFOVAC CAN ASSY, W/ GEL, 10 PK V.A.C. WhiteFoam Dressings

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)