BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    NIBEC CO LTD

    Reg #: 3007679154 · FEI: 3007679154 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NIBEC CO LTD
    Registration Number
    3007679154
    FEI Number
    3007679154
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Iwol Electricity-electronic Agro-Industrial Complex, 116 Bamdi-gil, Iwol-myeon
    City
    Jincheon-gun Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K150079

    Owner / Operator

    Firm Name
    NIBEC Co Ltd
    Operator Number
    10038845
    Address
    116, Bamdi-gil, Iwol-myeon Jincheon-gun
    City
    Jincheon
    State
    Chungbuk
    Postal Code
    27816
    Country
    KR
    Correspondent
    Yoon Jeong Park

    US Agent

    Business Name
    Industrial Science & Technology Network, Inc.
    Contact Name
    Lisa Conner
    Address
    1200 Corporate Blvd., Suite 10C
    City
    Lancaster
    State
    PA
    ZIP
    17601
    Country
    US
    Email
    [email protected]
    Phone
    717 5221739

    Products

    Device Name Product Code
    Bone Grafting Material, Animal Source NPM
    Barrier, Animal Source, Intraoral NPL

    Proprietary Names

    Regenomer Straumann Regenomer OCS-B Straumann XenoGraft Creos Xenogain Instradent Xenograft Neodent XenoGraft GuidOss RegenoGide Instradent Membrane bone grafting material, animal source OCS-B Collagen Creos Xenogain Collagen Straumann XenoFlex

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)