Data / Medical devices / South Korea / Dalim Medical Corp.
Dalim Medical Corp.: FDA-registered device maker in Bucheon-si Gyeonggi, South Korea, 1 510(k) clearance
Dalim Medical Corp. is registered with the FDA (registration 3020347456) in Bucheon-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020347456
- Address
- &609, 397, Seokcheon-ro, Bucheon-si Gyeonggi, South Korea, 14449
- Owner or operator
- Dalim Medical corp. (10092204)
- Roles
- Manufacturer
- First device listed
- December 12, 2024
- Registered through
- 2026
- Brand names listed
- Uni-port
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscopic Single Port Access Device | OTJ | 2 | 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 |
|---|---|---|---|---|---|---|
| January 16, 2024 | K232062 | Uni-port | OTJ | Substantially Equivalent | Dalim Medical Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 16, 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.