BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    STERLINK plus Sterilizer with STERLOAD™ Cassette

    Reg #: 3016075971 · FEI: 3016075971 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Plasmapp Co., Ltd.
    Registration Number
    3016075971
    FEI Number
    3016075971
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, 161, 388beon-gil, Asanbaelli-ro, Eumbong-myeon
    City
    Asan-si Chungnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231169

    Owner / Operator

    Firm Name
    Plasmapp Co., Ltd.
    Operator Number
    10083074
    Address
    BVC-111, 125, Gwahak-ro
    City
    Yuseong-gu
    State
    Daejeon
    Postal Code
    34141
    Country
    KR
    Correspondent
    Youbong Lim

    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
    Indicator, Physical/Chemical Sterilization Process JOJ
    Sterilizer, Chemical MLR
    Indicator, Biological Sterilization Process FRC
    Wrap, Sterilization FRG

    Proprietary Names

    STERLINK plus Sterilizer with STERLOAD™ Cassette Tyvek® Roll with CI for STERLINK™ Sterilizer Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42)

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device