BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ARKRAY Factory, Inc.

    Reg #: 3003422726 · FEI: 3003422726 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    20

    Registration Details

    Registration Name
    ARKRAY Factory, Inc.
    Registration Number
    3003422726
    FEI Number
    3003422726
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1480 Koji, Konan-cho
    City
    Koka-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K162822

    Owner / Operator

    Firm Name
    ARKRAY FACTORY USA, Inc.
    Operator Number
    8030316
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    Postal Code
    33122
    Country
    US

    Products

    Device Name Product Code
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Calibrator, Secondary JIT
    Assay, Glycosylated Hemoglobin LCP
    Hemoglobin A1c Test System PDJ
    Automated Urinalysis System KQO
    Blood, Occult, Colorimetric, In Urine JIO
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Test, Urine Leukocyte LJX
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Refractometer For Clinical Use JRE
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Counter, Urine Particle LKM
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    SillHa paper Test Strip Kit SillHa LH-4912 Oral Wellness System ADAMS A1c HA-8180V Calibrator 80 AUTION MAX AX-4060 Urinalysis System AUTION Sticks 9EB S.G. Calibrator H ReliOn Premier Lancing Device Multi-Lancet Device 2 AUTOMATED URINALYSIS SYSTEM AX-4280 AUTION EYE AI-4510 AUTION Sticks 10EA Test Strips AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System GLUCOCARD 01-mini ReliOn micro AUTION MAX AX-4030

    Establishment Types

    Manufacture Medical Device