BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD

    Reg #: 9610633 · FEI: 3002806693 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    60
    Establishment Types
    3
    Classifications
    30

    Registration Details

    Registration Name
    SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD
    Registration Number
    9610633
    FEI Number
    3002806693
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NORTHERN RD., CHILTON INDUSTRIAL ESTATE
    City
    SUDBURY Suffolk
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K113216

    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
    Felix Akinrinola
    Address
    Point Of Care Headquarters, 333 Coney Street
    City
    East Walpole
    State
    MA
    ZIP
    02032
    Country
    US
    Email
    [email protected]
    Phone
    781 8561738

    Products

    Device Name Product Code
    Acid, Lactic, Enzymatic Method KHP
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Calcium JFP
    Electrode, Ion Specific, Potassium CEM
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Electrode, Ion Specific, Sodium JGS
    Instrument, Hematocrit, Automated GKF
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Tube, Collection, Capillary Blood GIO
    System, Hemoglobin, Automated GKR
    Glucose Oxidase, Glucose CGA
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Assay, Glycosylated Hemoglobin LCP
    Ph Buffer JCC
    Diluent, Blood Cell GIF
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Refractometer For Clinical Use JRE
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Test, Urine Leukocyte LJX
    Automated Urinalysis System KQO
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Enzymatic Method, Creatinine JFY
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Blood, Occult, Enzymatic Method, In Urine JIP
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Visual, Pregnancy Hcg, Prescription Use JHI
    Calibrator, Multi-Analyte Mixture JIX
    Blood, Occult, Colorimetric, In Urine JIO

    Proprietary Names

    Rapidpoint 500 System Lactate Rapidlab 348 Blood Gas Systems Family Rapidpoint 400/405/500 systems Pleural Fluid RAPIDPOINT 405 RAPIDPOINT 500 Multicap Blood Collection Capillaries Capillary Caps Luer Capillary Blood Gas Blood Collection Capillary Tubes Plastic Capillaries Model 614 M614 M600 Series M600 Rapidlab 1200 Rapidlab Blood Gas Systems Rapidlab 800 Series Rapidlab 1200 Series DCA Systems DCA Vantage 800 SERIES M860 Imidazole Buffer Solution Blood Gas Systems Buffer IMMULITE 2000 Multi-Diluent 2 ADVIA Centaur Multi-Diluent 3 (M-Dil 3) ADVIA Centaur Multi-Diluent 11 (M-Dil 11) Blood Gas Systems 600 Series Blood Gas ADVIA Centaur Multi-Diluent 15 IMMULITE 2000 IgG/IgM Sample Diluent Atellica IM Multi-Diluent 12 (M-Dil 12) Atellica IM Multi-Diluent 13 (M-Dil 13) Atellica IM Multi-Diluent 2 (M-Dil 2) Atellica IM Multi-Diluent 1 (M-Dil 1) Atellica IM Multi-Diluent 10 (M-Dil 10) Atellica IM Multi-Diluent 11 (M-Dil 11) Atellica IM Multi-Diluent 3 (M-Dil 3) Atellica IM Multi-Diluent 15 (M-Dil 15) ADVIA Centaur Multi-Diluent 10 (M-Dil 10) ADVIA Centaur Multi-Diluent 1 (M-Dil 1) Atellica HEMA Diluent (HEMA Diluent) IMMULITE 2000 Multi-Diluent 1 ADVIA Centaur Multi-Diluent 2 (M-Dil 2) MAGIC LITE INTACT PTH DILUENT Ictotest RAPIDPoint® 500e Blood Gas System iCa++ Quick Sampler Rapidpoint 400 Rapidpoint Blood Gas Rapidpoint 400 Series 248 BG System Clinitek Status+ Clinitek Status CT Status CT Status+ CLINITEK Novus 10 Urinalysis Cassette CLINITEK Novus Calibration Kit CLINITEK Novus Automated Urine Chemistry Analyzer

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device