Data / Medical devices / South Korea / Ceragem Co., Ltd.
Ceragem Co., Ltd.: FDA-registered device maker in Cheonan-si, Seobuk-gu Chungnam, South Korea, 7 510(k) clearances
Ceragem Co., Ltd. is registered with the FDA (registration 3002849858) in Cheonan-si, Seobuk-gu Chungnam, South Korea. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002849858
- Address
- 10, Jeongja 1-gil, Seonggeo-eup, Cheonan-si, Seobuk-gu Chungnam, South Korea, 31045
- Owner or operator
- CERAGEM CO., LTD. (9039475)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 1, 1999
- Registered through
- 2026
- Brand names listed
- CELLUNIC MEDISPA PRO, Ceragem Automatic Thermal Massager (CGM MB-2401), Ceragem Automatic Thermal Massager (CGM-MB-1902), Ceragem Automatic Thermal Massager (Model CGM MS-2301 / CGM MS-2302), Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702, Ceragem Automatic Thermal Massager, Model CGM MB-2301 & CGM MB-2302, Ceragem Automatic Thermal Massager, Model CGM-MB-1101, Ceragem Automatic Thermal Massager, Model CGM-MB-1701 & CGM-MB-1702 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| Table, Physical Therapy, Multi Function | JFB | 2 | Manufacturer | accessdata.fda.gov |
| Vibrator, Therapeutic | IRO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2025 | K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) | JFB | Substantially Equivalent | Ceragem Co., Ltd. | accessdata.fda.gov |
| January 8, 2025 | K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) | JFB | Substantially Equivalent | Ceragem Co., Ltd. | accessdata.fda.gov |
| November 27, 2024 | K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) | JFB | Substantially Equivalent | Ceragem Co., Ltd. | accessdata.fda.gov |
| June 17, 2022 | K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | JFB | Substantially Equivalent | Ceragem Co., Ltd. | accessdata.fda.gov |
| March 18, 2021 | K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | JFB | Substantially Equivalent | Ceragem Co., Ltd. | accessdata.fda.gov |
| March 2, 2021 | K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901 | JFB | Substantially Equivalent | Ceragem Co., Ltd. | accessdata.fda.gov |
| December 17, 2014 | K140592 | CERAGEM AUTOMATIC THERMAL MASSAGER | JFB | Substantially Equivalent | Ceragem International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Powered Inflatable Tube
- All makers of Table, Physical Therapy, Multi Function
- All makers of Vibrator, Therapeutic
- All makers of Massager, Therapeutic, Electric
- All makers of Pad, Heating, Powered
Updated July 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.