BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    GREINER BIO-ONE GMBH

    Reg #: 8020040 · FEI: 3000974732 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    76
    Establishment Types
    5
    Classifications
    16

    Registration Details

    Registration Name
    GREINER BIO-ONE GMBH
    Registration Number
    8020040
    FEI Number
    3000974732
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BAD HALLER STRASSE 32
    City
    KREMSMUENSTER Oberosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K960857

    Owner / Operator

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

    US Agent

    Business Name
    GREINER BIO-ONE NORTH AMERICA, INC.
    Contact Name
    Angela Drysdale
    Address
    4238 Capital Drive
    City
    Monroe
    State
    NC
    ZIP
    28110
    Country
    US
    Email
    [email protected]
    Phone
    704 7768646

    Products

    Device Name Product Code
    Cannula, Injection FGY
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Needle, Hypodermic, Single Lumen FMI
    Transport Medium, Notified Per The Vtm Guidance QMC
    Container, Specimen, Sterile FMH
    Tube, Collection, Capillary Blood GIO
    Device, Specimen Collection LIO
    Culture Media, Non-Propagating Transport JSM
    Container, Specimen, Non-Sterile NNI
    Tubes, Vacuum Sample, With Anticoagulant GIM
    Blood/Plasma Collection Device For Dna Testing PJE
    Set, Administration, Intravascular FPA
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Tourniquet, Nonpneumatic GAX
    Culture Media, Non-Selective And Non-Differential JSG

    Proprietary Names

    Plastic Cannula HOLDEX VACUETTE® Urine CCM Tube+Urine STB Tube+Urine Cup with Transfer Device VACUETTE® Urine CCM Tube+Urine Cup with Transfer Device VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Transfer Device VACUETTE® Urine CCM Tube+Z Urine No Additive Tube+Urine Cup with Transfer Device VACUETTE Blood Collection Tube Lithium Heparin VACUETTE Blood Collection Tube Lithium Heparin Sep MiniCollect Blood Collection Tube Lithium Heparin MiniCollect Bllod Collection Tube Lithium Heparin Sep HOLDEX Single-Use Holder PP, single-packed Vacuette Blood Collection Tubes No Additive Vacuette Blood Collection Tubes K3EDTA Vacuette Virus Stabilization Tube Phosphate Buffered Saline Tube VACUETTE Safety Blood Collection/Infusion Set VACUETTE Luer Adapter Vacuette Safety Blood Collection / Infusion Set MiniCollect Blood Collection Tubes Z Serum MiniCollect Blood Collection Tubes Z Serum Sep MiniCollect Blood Collection Tubes K3EDTA MiniCollect Tube K2E EDTA K2 MiniCollect Complete K2E EDTA K2 VACUETTE Blood Collection Tube K2EDTA VACUETTE Blood Collection Tube K3EDTA VACUETTE® SAFELINK Holder with male luer lock 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 MiniCollect Capillary Vacuette Blood Collection Tubes Serum Clot Activator Vacuette Blood Collection Tubes with K3EDTA MiniCollect Blood Collection Tube K2EDTA VACUETTE Urine CCM Tube VACUETTE Urine CCM Tube convenience kit SECONDARY Tubes SIMPLEX SECONDARY Tubes MULTIPLEX Vacuette Urine Transfer Device Urine STB Set Vacuette Quickshield Complete PLUS Safety Tube Holder Vacuette Quickshield Complete Safety Tube Holder Vacuette Blood Culture Holder Vacuette Safety Blood Collection Set plus Luer Adapter with pre-attached Blood Culture Holder VACUETTE Multiple Use Drawing Needle Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.8% Vacuette Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.2% Vacuette Blood Collection Tubes K2EDTA Vacuette Blood Collection Tubes Serum with Clot Activator and Gel VACUETTE Blood Collection Tube Serum Clot Activator Vacuette Standard Tube Holder (short version) Vacuette Standard Tube Holder (long version) VACUETTE Blood Collection Tube with Sodium Heparin Vacuette Blood Collection Tubes FE Sodium Fluoride / K3 EDTA Vacuette Blood Collection Tube FX Sodium Fluoride / Potassium Oxalate VACUETTE Blood Collection Tube Trace Element No Additive VACUETTE Blood Collection Tube Trace Element Sodium Heparin Vacuette Blood Collection Tubes with K2EDTA and Gel VACUETTE Blood Collection Tubes with Clot Activator and Gel VACUETTE Blood Collection Tubes with Clot Activator VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set MiniCollect Lancelino, safety lancets VACUETTE Safety Blood Collection Set VACUETTE SAFETY Winged Set and Luer Adapter Vacuette Visio Plus Needles VACUETTE Tourniquet VACUETTE Tourniquet for children VACUETTE Disposable Tourniquet VACUETTE QUICKSHIELD Safety Tube Holder Vacuette Blood Collection Tubes Serum with Clot Activator Vacuette Blood Collection Tubes with K2EDTA

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device