BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Ora-Aid (models: OB23, OB53)

    Reg #: 3011276993 · FEI: 3011276993 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOSTECH CO., LTD.
    Registration Number
    3011276993
    FEI Number
    3011276993
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    274-46, Wonnamsandan-ro, Wonnam-myeon
    City
    Eumseong-gun Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K211851

    Owner / Operator

    Firm Name
    BIOSTECH CO., LTD.
    Operator Number
    10061536
    Address
    274-46, Wonnamsandan-ro, Wonnam-myeon
    City
    Eumseong-gun
    State
    Chungbuk
    Postal Code
    27721
    Country
    KR
    Correspondent
    SangWoon Kwak

    US Agent

    Business Name
    INNO SENSE, INC.
    Contact Name
    RYAN HWANG
    Address
    210 SYLVAN AVENUE SUITE 24
    City
    Englewd Clfs
    State
    NJ
    ZIP
    07632
    Country
    US
    Email
    [email protected]
    Phone
    201 4319052

    Products

    Device Name Product Code
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Oral Wound Dressing OLR

    Proprietary Names

    Ora-Aid (models: OB23, OB53) Augma Shield (model: OB23)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)