Data / Medical devices / South Korea / Dimedi Korea Inc
Dimedi Korea Inc: FDA-registered device maker in Busan, South Korea, 1 510(k) clearance
Dimedi Korea Inc is registered with the FDA (registration 3029913483) in Busan, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3029913483
- Address
- Rm.201,1 Mandeok 3-ro 16beon-gil, Buk-gu, Busan, Busan, South Korea, 46570
- Owner or operator
- DIMEDI KOREA INC (10094323)
- Roles
- Manufacturer
- First device listed
- November 23, 2025
- Registered through
- 2027
- Brand names listed
- GOYO Mouthpiece S, GOYO SLIM FIT MOUTH GUARD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mouthguard, Over-The-Counter | OBR | U | 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 |
|---|---|---|---|---|---|---|
| April 17, 2024 | K232238 | Goyo Mouthpiece S | OBR | Substantially Equivalent | Dimedikorea | accessdata.fda.gov |
Compare with other makers
Updated April 17, 2024. 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.