BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MOTIF MEDICAL LUNA

    Reg #: 3013561139 · FEI: 3013561139 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CIMILRE CO., LTD.
    Registration Number
    3013561139
    FEI Number
    3013561139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    97-14, Seongnam-ro, Mokcheon-eup,, Dongnam-gu
    City
    Cheonan-si Chungnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K162870

    Owner / Operator

    Firm Name
    CIMILRE CO.,LTD
    Operator Number
    10054474
    Address
    97-14, Seongnam-ro, Mokcheon-eup,, Dongnam-gu
    City
    Cheonan-si
    State
    Chungnam
    Postal Code
    31234
    Country
    KR
    Correspondent
    Misun Na

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    MOTIF MEDICAL LUNA AMEDA MYA PRO HYGEIA FIT CIMILRE F1 AMEDA MYA Motif Luna with Battery CIMILRE S3 CIMILRE S6 CIMILRE P1 CIMILRE S6 plus

    Establishment Types

    Manufacture Medical Device