BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    RECENSMEDICAL INC.

    Reg #: 3015351183 · FEI: 3015351183 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    RECENSMEDICAL INC.
    Registration Number
    3015351183
    FEI Number
    3015351183
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3F, 64-10, Dongtangiheung-ro, Dongtan-gu, Hwaseong-si, Gyeonggi-do Republic of Korea
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K253114

    Owner / Operator

    Firm Name
    Recensmedical Inc.
    Operator Number
    10082084
    Address
    #908, SK V1 center, 830 Dongtansunhwan-daero, Hwaseong-si, Gyeonggi-do, Republic of Korea
    City
    Hwaseong-si
    State
    Gyeonggi
    Postal Code
    18468
    Country
    KR

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St Ste 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    Vapocoolant Device MLY
    Unit, Cryosurgical, Accessories GEH
    QZQ

    Proprietary Names

    TargetCool TargetCool-e OcuCool

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198