BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    TAEWOONG MEDICAL CO., LTD

    Reg #: 3003902943 · FEI: 3003902943 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    10

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    Registration Details

    Registration Name
    TAEWOONG MEDICAL CO., LTD
    Registration Number
    3003902943
    FEI Number
    3003902943
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14 Gojeong-ro, Wolgot-myeon
    City
    Gimpo-Si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K251123

    Owner / Operator

    Firm Name
    TAEWOONG MEDICAL CO., LTD
    Operator Number
    9054381
    Address
    14, Gojeong-ro, Wolgot-myeon
    City
    Gimpo-Si
    State
    Gyeonggi
    Postal Code
    10022
    Country
    KR
    Correspondent
    Yongjin Kim

    US Agent

    Business Name
    Biologics Consulting
    Contact Name
    MARGARET VERNON
    Address
    100 DAINGERFIELD ROAD, SUITE 400
    City
    Alexandria
    State
    VA
    ZIP
    22314
    Country
    US
    Email
    [email protected]
    Phone
    720 8833633

    Products

    Device Name Product Code
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Prosthesis, Esophageal ESW
    Snare, Non-Electrical FGX
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Stent, Metallic, Expandable, Duodenal MUM
    Stent, Colonic, Metallic, Expandable MQR
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Forceps, Biopsy, Non-Electric FCL
    Pancreatic Stent, Covered, Metallic, Removable PCU
    Gallbladder Drainage Stent And Delivery System QXH

    Proprietary Names

    Niti-S Biliary Slim M Stent Niti-S Biliary Stent Niti-S Bilary Stent Esophageal TTS Stent Snare Sphincterotome Niti-S Colonic Comfort Stent Niti-S Duodenal Comfort Stent Guidewire Niti-S Esophageal Stent Cystotome Biopsy Forceps Niti-S SPAXUS Stent Niti-S Biliary Speed D Stent

    Establishment Types

    Manufacture Medical Device