FDA Registration
Active
🇺🇸 United States
MEDIBEACON INC.
Reg #: 3027576156
·
FEI: 3027576156
·
Expires 2026
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDIBEACON INC.
- Registration Number
- 3027576156
- FEI Number
- 3027576156
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 425 N New Ballas Rd Ste 100
- City
- Creve Coeur
- State
- MO
- ZIP
- 63141
- Country
- US
Regulatory Submissions
- PMA Number
- P230019
Owner / Operator
- Firm Name
- MediBeacon Inc.
- Operator Number
- 10095100
- Address
- 425 N. New Ballas Road, Suite 100
- City
- Creve Coeur
- State
- MO
- Postal Code
- 63141
- Country
- US
- Correspondent
- Richard Dorshow
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transdermal Test For Assessment Of Glomerular Filtration Rate | SDK | Class 3 | Unknown | No | 2026-01-23 |
Proprietary Names
Lumitrace (relmapirazin) Injection
MediBeacon Transdermal GFR System
MediBeacon TGFR Monitor
MediBeacon TGFR Disposable Ring
MediBeacon TGFR Reusable Sensor
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility