Data / Medical devices / United States / Sweetbio
Sweetbio: FDA-registered device maker in Memphis, TN, United States, 1 510(k) clearance
Sweetbio is registered with the FDA (registration 3015547002) in Memphis, TN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015547002
- Address
- 460 S. Highland St. Floor 2, Memphis, TN, United States, 38111
- Owner or operator
- SweetBio (10060718)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 4, 2023
- Registered through
- 2026
- Brand names listed
- APIS, VERIS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 13, 2023 | K222143 | APIS (R), VERIS (TM) | FRO | Substantially Equivalent | Sweetbio, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 13, 2023. 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.