BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BiometerPlus USA, Inc.

    Reg #: 3010830834 · FEI: 3004525092 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    59
    Establishment Types
    3
    Classifications
    22

    Registration Details

    Registration Name
    BiometerPlus USA, Inc.
    Registration Number
    3010830834
    FEI Number
    3004525092
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    ZIP
    94539
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203196

    Owner / Operator

    Firm Name
    BiometerPlus USA, Inc.
    Operator Number
    10046647
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    Postal Code
    94539
    Country
    US
    Correspondent
    Jian Zhou

    Products

    Device Name Product Code
    Acid, Ferric Ion-Sulfuric, Cholesterol CHD
    Holder, Film, X-Ray EGZ
    Tape And Bandage, Adhesive KGX
    Meter, Peak Flow, Spirometry BZH
    Syringe, Antistick MEG
    Syringe, Piston FMF
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA
    Needle, Hypodermic, Single Lumen FMI
    Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl LBT
    Calibrator, Primary JIS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Oxidase, Glucose CGA
    Toothbrush, Manual EFW
    System, Test, Blood Glucose, Over The Counter NBW
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Set, Administration, Intravascular FPA
    Floss, Dental JES
    Nadp Reduction, 6-Phosphogluconate Dehydrogenase JND
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Orthosis, Cervical-Thoracic, Rigid IQF
    Speculum, Vaginal, Nonmetal HIB

    Proprietary Names

    Q.STEPS Glucose/Cholesterol/Uric Acid Monitoring System BIO Dental Radiographic Film BIO TAPE and BANDAGE BIO Peak Flow Meter BIO-S30032138LL, disposable syringes Luer Lock with needles, 3 ml, 21G x 38mm BIO-S30102036LL, disposable syringes Luer Lock with needles, 10 ml, 20G x 36mm BIO-V052713, Vaccination Syringes, 0.5 ml, 20G x 32mm, 27G x 13mm BIO-S30052038LL, disposable syringes Luer Lock with needles, 5 ml, 20G x 38mm BIO-S30202038LL, disposable syringes Luer Lock with needles, 20 ml, 20G x 38mm BIO-S30032232LL, disposable syringes Luer Lock with needles, 3 ml, 22G x 32mm BIO-S30032325LL, disposable syringes Luer Lock with needles, 3 ml, 23G x 25mm BIO-V052325, Vaccination Syringes, 0.5 ml, 20G x 32mm, 23G x 25mm BIO-V052032, Vaccination Syringes, 0.5 ml, 20G x 32mm, 22G x 32mm BIO-V102516, Vaccination Syringes, 1 ml, 20G x 32mm, 25G x 16mm BIO-S30052132LL, disposable syringes Luer Lock with needles, 5 ml, 21G x 32mm BIO-S30102132LL, disposable syringes Luer Lock with needles, 10 ml, 21G x 32mm BIO-S30032038LL, disposable syringes Luer Lock with needles, 3 ml, 20G x 38mm BIO-S30102032LL, disposable syringes Luer Lock with needles, 10 ml, 20G x 32mm BIO-S3003LL, 3-part disposable syringes Luer Lock, 3 ml BIO-S3005LL, 3-part disposable syringes Luer Lock, 5 ml BIO-S3020LL, 3-part disposable syringes Luer Lock, 20 ml BIO-S3010LL, 3-part disposable syringes Luer Lock, 10 ml JOFRI-GSL800S, Gloves surgery latex, sterile, and disposable. Size 8, pair JOFRI-GSL712S, Gloves surgery latex, sterile, and disposable. Size 7 1/2, pair JOFRI-GELMNS, Gloves examination, latex, non sterile, ambidextrous, disposable. Medium size JOFRI-GELLS, Gloves examination, latex, none sterile, ambidextrous, disposable. Large size JOFRI-GELMS, Gloves examination, latex, sterile, ambidextrous, disposable. Medium size JOFRI-GELSNS, Gloves examination, latex, non sterile, ambidextrous, disposable. Small size JOFRI-GEPMS, Gloves examintaion, polyethylene, sterile, ambidextrous, disposabe. Medum size JOFRI-GSL812S, Gloves surgery latex, sterile, and disposable. Size 8 1/2, pair JOFRI-GELLS, Gloves examination, latex, sterile, ambidextrous, disposable. Large size JOFRI-GSL612S, Gloves surgery latex, sterile and disposable. Size 6 1/2, pair JOFRI-GSL700S, Gloves surgery latex, sterile, and disposable. Size 7, pair JOFRI-GEPLS, Gloves examintaion, polyethylene, sterile, ambidextrous, disposabe. Large size JOFRI-GELSS, Gloves examination, latex, sterile, ambidextrous, disposable. Small size BIO-N1832, Hypodermic needles, 18G x 32mm BIO-N2032, Hypodermic needles, 20G x 32mm BIO-N2132, Hypodermic needles, 21G x 32mm BIO-N2325, Hypodermic needles, 23G x 25mm BIO-N2232, Hypodermic needles, 22G x 32mm BIO-N2038, Hypodermic needles, 20G x 38mm BIO-N2138, Hypodermic needles, 21G x 38mm BIO-N2516, Hypodermic needles, 25G x 16mm BIO-N2713, Hypodermic needles, 27G x 13mm BIO-N2238, Hypodermic needles, 22G x 38mm BIO Aseptic Irrigation Syringe Q.STEPS Cholesterol Meter System Q.Steps G/C Monitoring system(Glucose/TC); Q.Steps Glucose Meter system BIO Toothbrush BIO-053108, Insulin syringes, 0.5 ml 31G x 8mm, 0 to 50 units BIO-I102713, Insulin syringes, 1 ml, 27G x 13mm, 0 to 100 units Q. CHECK ALL-IN-1 HEALTH MONITORING SYSTEM (Glucose, Uric Acid, Total Cholesterol, Triglyceride, HDL & LDL) Q.CHECK LPTs 3-in-1 METER SYSTEM(TC/TG/HDL/Cal LDL) BIO- IN02, Infusion sets, 60 Drops per minute BIO- IN01, Infusion sets, 20 Drops per minute BIO Dental Floss Q.Steps G/C Monitoring system(Glucose/TC); Q.StepsGlucose Monitoring system BIO Neck Fixation Brace BIO Vaginal Speculum

    Establishment Types

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