Data / Medical devices / United States / Medibeacon Inc.
Medibeacon Inc.: FDA-registered device maker in Creve Coeur, MO, United States, 1 PMA approval
Medibeacon Inc. is registered with the FDA (registration 3027576156) in Creve Coeur, MO, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated January 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027576156
- Address
- 425 N New Ballas Rd Ste 100, Creve Coeur, MO, United States, 63141
- Owner or operator
- MediBeacon Inc. (10095100)
- Roles
- Specification developer
- First device listed
- January 23, 2026
- Registered through
- 2026
- Brand names listed
- Lumitrace (relmapirazin) Injection, MediBeacon TGFR Disposable Ring, MediBeacon TGFR Monitor, MediBeacon TGFR Reusable Sensor, MediBeacon Transdermal GFR System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transdermal Test For Assessment Of Glomerular Filtration Rate | SDK | 3 | Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 17, 2025 | P230019 | MediBeacon® Transdermal GFR Measurement System (TGFR) | SDK | 4 | October 2, 2026 | accessdata.fda.gov |
Compare with other makers
Updated October 2, 2026. 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.