BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KITAZATO CORPORATION

    Reg #: 3008876063 · FEI: 3008876063 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    51
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    KITAZATO CORPORATION
    Registration Number
    3008876063
    FEI Number
    3008876063
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    100-10 Yanagishima
    City
    Fuji Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K112695

    Owner / Operator

    Firm Name
    Kitazato Corporation
    Operator Number
    10045321
    Address
    100-10 Yanagishima
    City
    Fuji
    State
    Shizuoka
    Postal Code
    416-0932
    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
    Labware, Assisted Reproduction MQK
    Needle, Assisted Reproduction MQE
    Media, Reproductive MQL
    Catheter, Assisted Reproduction MQF
    Tubing, Noninvasive GAZ
    Microtools, Assisted Reproduction (Pipettes), Exempt PUC
    Media, Reproductive, Exempt QKI
    Labware, Assisted Reproduction, Exempt PUD

    Proprietary Names

    CryotopCL Kitazato OPU Needle with Connection Tube (model number Type2) Kitazato OPU Reduced Needle (model number Type3) Kitazato OPU Two-Stage Reduced Needle (model number Type4) Catheter 3Fr or 4Fr and Guide with Obturator Catheter 3Fr or 4Fr and Guide Stylet for Guide Kitazato IUI Catheter without Stainless Steel Center Core Type, 10 cm, model number Type 2-v1 Kitazato IUI Catheter without Stainless Steel Center Core Type, 7 cm, model number Type 2-v2 Kitazato IUI Catheter with Stainless Steel Center Core Type, 10 cm, model number Type 1-v1 Kitazato IUI Catheter with Stainless Steel Center Core Type, 7 cm, model number Type 1-v2 KITAZATO VACUUM LINE 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 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, 18 cm, model number Type 4-v1 and Type 4-v2 Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number Type 3-v1 Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18 cm, model number Type 3-v2 CryotopUS Cryotop Vitrification Kit and Cryotop Thawing Kit SepaSperm Washing Solution SepaSperm Solution Kitazato OPU Reduced Needle, model number Type 3 Kitazato OPU Needle with Connection Tube, model number Type 2 Sperm Fridge Sperm Freeze Micro Tools Hypure Oil Hypure oil Single Step Culture Medium Sigle Step Culture Medium with rHA Single Step Culture Medium with HAS CryotopSC Trial Catheter 4.7Fr (Trial EC-PRO) Stylet for Guide (EC-PRO Stylet) Echogenic Catheter 4.7Fr Supported (EC-PRO Master Supported) Trial Catheter 4.7Fr Supported (Trial EC-PRO Supported) Catheters 4.7Fr(EC-PRO) Echogenic Trial Catheter 4.7Fr(Trial EC-PRO Master) Echogenic Trial Catheter 4.7Fr Supported (Trial EC-PRO Master Supported) Catheter 4.7Fr Supported (EC-PRO Supported) Echogenic Catheter 4.7Fr(EC-PRO Master) PBS(-), Phosphate Buffered Saline Sequential Culture Media Cryotop®US-scoop Cryotop®US-flash Cleavage Medium [without HSA/rHA, with HSA, with rHA] Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA] Repro Plate-K1(6well) , 10pieces Repro Plate-K1(6well), 1piece

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198