BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GREINER BIO-ONE NORTH AMERICA, INC.

    Reg #: 1125230 · FEI: 3001451379 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    GREINER BIO-ONE NORTH AMERICA, INC.
    Registration Number
    1125230
    FEI Number
    3001451379
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4238 Capital Dr
    City
    MONROE
    State
    NC
    ZIP
    28110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K971236

    Owner / Operator

    Firm Name
    GREINER BIO-ONE NA
    Operator Number
    8020040
    Address
    4238 Capital Drive
    City
    Monroe
    State
    NC
    Postal Code
    28110
    Country
    US

    Products

    Device Name Product Code
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Blood/Plasma Collection Device For Dna Testing PJE
    Container, Specimen, Sterile FMH
    Needle, Hypodermic, Single Lumen FMI
    Tubes, Vacuum Sample, With Anticoagulant GIM

    Proprietary Names

    Vacuette Blood Collection Tubes K2EDTA VACUETTE Blood Collection Tube K2EDTA VACUETTE Blood Collection Tube K3EDTA VACUETTE Blood Collection Tube Trace Element No Additive VACUETTE Blood Collection Tube Trace Element Sodium Heparin Vacuette Blood Collection Tubes with K3EDTA VACUETTE Urine Beaker MiniCollect Carrier Tubes Vacuette Urine Beaker with Integrated Transfer Device VACUETTE Urine Transfer Device MiniCollect Funnel Blood Transfer Unit Vacuette No Additive Urine Tubes VACUETTE No Additive Tubes VACUETTE Sample Transfer Unit Vacuette Urine STB tubes Vacuette Blood Collection Tubes No Additive Vacuette Blood Collection Tubes Serum with Clot Activator and Gel VACUETTE Blood Collection Tube Serum Clot Activator VACUETTE Blood Collection Tube with Sodium Heparin VACUETTE QUICKSHIELD Safety Tube Holder Vacuette Blood Collection Tubes K3EDTA Vacuette Blood Collection Tubes Serum with Clot Activator Vacuette Blood Collection Tubes with K2EDTA Vacuette Blood Collection Tubes Serum Clot Activator Vacuette Standard Tube Holder (short version) Vacuette Standard Tube Holder (long version) VACUETTE Blood Collection Tubes with Clot Activator and Gel VACUETTE Blood Collection Tubes with Clot Activator VACUETTE Blood Collection Tube Lithium Heparin VACUETTE Blood Collection Tube Lithium Heparin Sep Vacuette Blood Collection Tubes with K2EDTA and Gel Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.8% Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.2%

    Establishment Types

    Manufacture Medical Device