BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Siemens Healthcare Diagnostics Manufacturing Ltd.

    Reg #: 8020888 · FEI: 3007019572 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    73
    Establishment Types
    1
    Classifications
    51

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Manufacturing Ltd.
    Registration Number
    8020888
    FEI Number
    3007019572
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CHAPEL LANE
    City
    SWORDS Dublin
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K162977

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US

    US Agent

    Business Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Contact Name
    Mary Seeger
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US
    Email
    [email protected]
    Phone
    914 3254329

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Carcinoembryonic Antigen DHX
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX
    Test, Natriuretic Peptide NBC
    Myoglobin, Antigen, Antiserum, Control DDR
    Device, General Purpose, Hematology LOQ
    System, Test, Thyroid Autoantibody JZO
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer NIG
    Calibrators, Drug Mixture DKB
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Radioimmunoassay, Progesterone JLS
    Ferritin, Antigen, Antiserum, Control DBF
    Acid, Folic, Radioimmunoassay CGN
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Radioassay, Vitamin B12 CDD
    Visual, Pregnancy Hcg, Prescription Use JHI
    Ige, Antigen, Antiserum, Control DGC
    System, Test, Immunological, Antigen, Tumor MOI
    Fluorometric, Cortisol JFT
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Fluorescence Polarization Immunoassay, Theophylline LGS
    Enzyme Immunoassay, Digitoxin LFM
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Immunoassay Method, Troponin Subunit MMI
    Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) LGR
    Enzyme Immunoassay, Gentamicin LCD
    Enzyme Immunoassay, Digoxin KXT
    Radioimmunoassay, Estradiol CHP
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Radioimmunoassay, Free Thyroxine CEC
    Radioassay, Triiodothyronine Uptake KHQ
    Radioimmunoassay, Luteinizing Hormone CEP
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Radioimmunoassay, Vancomycin LEH
    Calibrator, Secondary JIT
    Fluorescent Immunoassay, Tobramycin LCR
    Endoscope, Neurological GWG
    Urinary Homocystine (Nonquantitative) Test System LPS
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Enzyme Immunoassay, Barbiturate DIS
    Radioimmunoassay, Total Triiodothyronine CDP
    Radioimmunoassay, Parathyroid Hormone CEW
    Calculator/Data Processing Module, For Clinical Use JQP
    Counter, Cell, Automated (Particle Counter) GKL
    Electrode, Ion-Specific, Chloride CGZ
    Bromcresol Purple Dye-Binding, Albumin CJW
    Calibrator, Multi-Analyte Mixture JIX
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM

    Proprietary Names

    ADVIA Hematology 2120i RoHS/REACH instruments ADVIA Centaur Analyzer, ADVIA Centaur Classic Atellica IM 1600 Analyzer Atellica IM Cleaner Atellica IM Wash Atellica IM Acid/Base Atellica IM 1300 Analyzer Atellica IM Acid Atellica IM Ancillary Seal Kit Atellica IM Base Atellica IM 1300 Analyzer (Fully Refurbished) Atellica IM 1600 Analyzer (Fully Refurbished) Atellica IM Total Triiodothyronine (T3) Atellica IM Total Triiodothyronine Diluent (T3 DIL) ADVIA Centaur Total Triiodothyronine Diluent (T3 DIL) ADVIA Centaur Acid and Base Reagents ADVIA Centaur Total Triiodothyronine (T3) ADVIA Centaur XP Analyzer ADVIA Centaur Total Triiodothyronine Master Curve Material (T3 MCM) Atellica IM Total Triiodothyronine Master Curve Material (T3 MCM) ADVIA Centaur CP Analyzer Atellica IM Probe Wash 3 (PW3) POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite ADVIA 120/2120 ADVIA Centaur XPT System ADVIA 120 Atellica CH IMT Standard A (IMT Standard A) Atellica CH Reagent Probe Cleaner 1 (RPC1) Atellica CH 930 Analyzer Atellica CH Cleaner Atellica CH EMPTY Atellica CH Reagent Probe Cleaner 4 (RPC4) Atellica CH Lamp Coolant (LC) Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge) Atellica CH Water Bath Additive (WBA) Atellica CH IMT Diluent (IMT Diluent) Atellica Direct Load Atellica CH Reagent Probe Cleaner 2 (RPC2) Atellica CH Diluent Atellica CH IMT Dilution Check (IMT Dilution Check) Atellica CH Check Reagent (CHK) Atellica CH Albumin BCP Calibrator (AlbP CAL) Atellica CH Wash Atellica CH Conditioner Atellica CH EMPTY1 Atellica CH HA1c_E High Volume Labels (50) Atellica CH EMPTY2 Atellica CH HA1c_E High Volume Bottles (5) Atellica CH HA1c_E High Volume Conversion Kit Atellica CH Lid Keying Feature Atellica CH 930 Analyzer (Fully Refurbished) Atellica Sample Handler Prime (Fully Refurbished) Atellica Sample Handler Additional Atellica CH Reaction Cuvette Segment Atellica CH Dilution Cuvette Segment Atellica Tube Top Sample Cup Atellica Sample Handler Prime Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Atellica Rack Handler Atellica CI Reaction Cuvette Segments Atellica CI Dilution Cuvette Segments Atellica CI Analyzer; (Model 1900) Atellica CH Albumin BCP (AlbP) Atellica Direct Connect for CI

    Establishment Types

    Manufacture Medical Device