BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Kitazato Corporation

    Reg #: 3008456389 · FEI: 3008456389 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Kitazato Corporation
    Registration Number
    3008456389
    FEI Number
    3008456389
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-1-8 Shibadaimon
    City
    Minato-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K162878

    Owner / Operator

    Firm Name
    Kitazato Corporation
    Operator Number
    10045322
    Address
    1-1-8 Shibadaimon
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    105-0012
    Country
    JP

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Catheter, Assisted Reproduction MQF
    Needle, Assisted Reproduction MQE

    Proprietary Names

    Stylet for Guide (EC-PRO Stylet) Echogenic Catheter 4.7Fr(EC-PRO Master) Trial Catheter 4.7Fr Supported (Trial EC-PRO Supported) Trial Catheter 4.7Fr (Trial EC-PRO) Catheters 4.7Fr(EC-PRO) Echogenic Trial Catheter 4.7Fr(Trial EC-PRO Master) Catheter 4.7Fr Supported (EC-PRO Supported) Echogenic Trial Catheter 4.7Fr Supported (Trial EC-PRO Master Supported) Echogenic Catheter 4.7Fr Supported (EC-PRO Master Supported) Catheter 3Fr or 4Fr and Guide Catheter 3Fr or 4Fr and Guide with Obturator Catheter 3Fr or 4Fr Stylet for Guide Kitazato OPU Reduced Needle (model number Type3) Kitazato OPU Needle with Connection Tube (model number Type2) Kitazato OPU Two-Stage Reduced Needle (model number Type4) Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2 Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1 Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 10 cm, model number Type 5-v3 and Type 5-v4 Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 10 cm, model number Type 4-v3 and Type 4-v4 Kitazato IUI Catheter with Outer Stiffener with Stainless Steel Core, 18 cm, model number Type 5-v1 and Type 5-v2 Kitazato IUI Catheter with Outer Stiffener with or without Stylet Cannula, 18 cm, model number Type 4-v1 and Type 4-v2 Kitazato OPU Reduced Needle, model number Type 3 Kitazato OPU Needle with Connection Tube, model number Type 2 Kitazato IUI Catheter with Stainless Steel Center Core Type, 7 cm, model number Type 1-v2 Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, model number Type 2-v1 Kitazato IUI Catheter with Stainless Steel Center Core Type, 10 cm, model number Type 1-v1 Kitazato IUI Catheter without Stainless Steel Center Core Type, 7 cm, model number Type 2-v2

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device