BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Miracell Co.,Ltd.

    Reg #: 3023346439 · FEI: 3023346439 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Miracell Co.,Ltd.
    Registration Number
    3023346439
    FEI Number
    3023346439
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B-601~608, 215, Galmachi-ro, Jungwon-gu,
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K250516

    Owner / Operator

    Firm Name
    Miracell Co.,Ltd.
    Operator Number
    10085629
    Address
    3F Taehyun Bldg 413 Eonju-ro, Gangnam-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    06222
    Country
    KR
    Correspondent
    Hyun S Shin

    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
    Centrifuge, Blood-Bank For In Vitro Diagnostic Use KSO
    Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate QBV

    Proprietary Names

    Smart M-Cell 2 Smart M-Cell 4 SMART M-CELL PRP Concentration System SMART M-CELL Bone Marrow Concentration System

    Establishment Types

    Manufacture Medical Device