BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KOGA ISOTOPE LTD.

    Reg #: 3002807408 · FEI: 3002807408 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    14

    Registration Details

    Registration Name
    KOGA ISOTOPE LTD.
    Registration Number
    3002807408
    FEI Number
    3002807408
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    53-6 Jinbo,Koka-cho
    City
    Koka-shi Shiga
    Country
    JP

    Owner / Operator

    Firm Name
    KOGA ISOTOPE LTD.
    Operator Number
    10025197
    Address
    53-6 Jinbo,Koka-cho
    City
    Koka-shi
    State
    Shiga
    Postal Code
    520-3404
    Country
    JP

    US Agent

    Business Name
    Center for Regulatory Services, Inc.
    Contact Name
    Kristi Smedley
    Address
    1536 Canoe House Rd
    City
    Jamaica
    State
    VA
    ZIP
    23079
    Country
    US
    Email
    [email protected]
    Phone
    703 7867674

    Products

    Device Name Product Code
    Hemostatic Device For Endoscopic Gastrointestinal Use QAU
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Labware, Assisted Reproduction, Exempt PUD
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Filler, Bone Void, Calcium Compound MQV
    Labware, Assisted Reproduction MQK
    Hemodialyzer, Re-Use, High Flux MSF
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Needle, Hypodermic, Single Lumen FMI
    System, Automated Platelet Aggregation JOZ
    Connector, Catheter GCD

    Proprietary Names

    PuraStat BD Vacutainer Rapid Serum Tube Accu-Chek Safe-T-Pro Plus Lancing Device Assure Lance Plus Capiject Safety Lancet OneTouch Delica Safety HemoCue Safety Lancet Assure Lance Heel Lancet Newborn Vitri Plate, Warm Plate Accu-Chek Softclix Cryotec (10 pieces) (Blue) BD Vacutainer REXEED SERIES DIALYZERS TSK Sterijeckt Disposable Hypodermic Needle BAPA tube for T-TAS 01 One Touch Delica Plus Lancinfg System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)