Data / Medical devices / South Korea / Sunbio,inc.
Sunbio,inc.: FDA-registered device maker in Incheon-si, South Korea, 1 510(k) clearance
Sunbio,inc. is registered with the FDA (registration 3013534361) in Incheon-si, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 5, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013534361
- Address
- 129 Eunbong-ro Namdong-gu, Incheon-si, South Korea, 21639
- Owner or operator
- SunBio,Inc. (10083497)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- November 24, 2021
- Registered through
- 2026
- Brand names listed
- MucoPEG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Saliva, Artificial | LFD | U | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| November 5, 2019 | K190144 | MucoPEG | LFD | Substantially Equivalent | Sunbio, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 5, 2019. 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.