BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Egens One Step HCG Urine Pregnancy Test Kit(s) (Strip, Cassette, Midstream I and Midstream II)

    Reg #: 3005607112 · FEI: 3003075526 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    WestRock Converting, LLC
    Registration Number
    3005607112
    FEI Number
    3003075526
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 FRITH DR., BLDG. A
    City
    RIDGEWAY
    State
    VA
    ZIP
    24148
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123050

    Owner / Operator

    Firm Name
    WestRock Converting, LLC
    Operator Number
    9056422
    Address
    5950 Grassy Creek Blvd.
    City
    Winston Salem
    State
    NC
    Postal Code
    27105
    Country
    US
    Correspondent
    Craig Smith

    Products

    Device Name Product Code
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    Egens One Step HCG Urine Pregnancy Test Kit(s) (Strip, Cassette, Midstream I and Midstream II)

    Establishment Types

    Repack or Relabel Medical Device