BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CERAGEM CO., LTD.

    Reg #: 3002849858 · FEI: 3002849858 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    CERAGEM CO., LTD.
    Registration Number
    3002849858
    FEI Number
    3002849858
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10, Jeongja 1-gil, Seonggeo-eup
    City
    Cheonan-si, Seobuk-gu Chungnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K250266

    Owner / Operator

    Firm Name
    CERAGEM CO., LTD.
    Operator Number
    9039475
    Address
    10, Jeongja 1-gil, Seonggeo-eup,
    City
    Cheonan-si, Seobuk-gu
    State
    Chungnam
    Postal Code
    31041
    Country
    KR
    Correspondent
    Brian Yang

    US Agent

    Business Name
    Provision Consulting Group, Inc.
    Contact Name
    Joyce Kwon
    Address
    13925 City Center Dr Ste 200
    City
    Chino Hills
    State
    CA
    ZIP
    91709
    Country
    US
    Email
    [email protected]
    Phone
    909 4933276

    Products

    Device Name Product Code
    Vibrator, Therapeutic IRO
    Massager, Therapeutic, Electric ISA
    Table, Physical Therapy, Multi Function JFB
    Massager, Powered Inflatable Tube IRP
    Pad, Heating, Powered IRT

    Proprietary Names

    Ceragem Automatic Thermal Massager (CGM MB-2401) Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 Ceragem Automatic Thermal Massager (CGM-MB-1902) Ceramix Mat M1; Ceramix Mat S1 Ceragem Automatic Thermal Massager, Model CGM-MB-1701 & CGM-MB-1702 Ceragem Automatic Thermal Massager, Model CGM-MB-1101 PAUSE M4 Massage Chair CELLUNIC MEDISPA PRO HEALAX I Shoulder PAUSE M8 (CGM EMCG-2404) PAUSE M10 (CGM EMCG-2403) PAUSE M6 Massage Chair PAUSE M6(s) Massage Chair Ceragem Automatic Thermal Massager (Model CGM MS-2301 / CGM MS-2302) Ceragem Automatic Thermal Massager, Model CGM-MB-1901 Ceragem Automatic Thermal Massager, Model CGM MB-2301 & CGM MB-2302

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device