BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    LENA KO CORPORATION

    Reg #: 3027283275 · FEI: 3027283275 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    LENA KO CORPORATION
    Registration Number
    3027283275
    FEI Number
    3027283275
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7F, No. 33, Sec. 1, Zhongxiao W. Rd.
    City
    Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K123849

    Owner / Operator

    Firm Name
    Lena Ko Corporation
    Operator Number
    10087600
    Address
    7F, No. 33, Sec. 1, Zhongxiao W. Rd.
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    10041
    Country
    TW
    Correspondent
    Jane Chu

    US Agent

    Business Name
    Compliance Engineering, Inc.
    Contact Name
    kk Grant
    Address
    2611 Merrick Road #66
    City
    Bellmore
    State
    NY
    ZIP
    11710
    Country
    US
    Email
    [email protected]
    Phone
    516 9847287

    Products

    Device Name Product Code
    Mouthguard, Over-The-Counter OBR
    Zinc Oxide Eugenol EMB
    Scraper, Tongue LCN
    Floss, Dental JES
    Toothbrush, Manual EFW

    Proprietary Names

    CVS FLNG CRWN RPR 1CT - 695108 CVS LST FL CR RPR 2CT - 572123 CVS TONGUE BR 2CT - 572131 CVS ADV ANGL FLSPK - 897706 CVS CMFRT FLSPK - 856262 CVS FLSSR MINT - 454376 CVS FINE MNT FLSR - 971455 CVS FLSSR FINE - 454381 CVS WHTNG FLOSSERV - 257711 CVS FLS THREADER 35CT - 976521 CVS ADVCD MNT FLSS - 542218 CVS SENS FLSPK - 978931 CVS SENS FLSRS - 737670 CVS MINT FLSSR - 853023 CVS INTRDNTL TGHT 16CT -933823 CVS INTRDNTL WIDE 16CT - 957833 CVS UT INTRDNTL BR 32CT - 227508 CVS INTRDNTL MOD 16CT - 214205 CVS INTRDNTL TB 16CT - 469136

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device