FEI 3009862700
Senseonics, Inc.
20451 Seneca Meadows Pkwy, Germantown, MD, US
MDR events6,973All time
Recalls1All time
Registered products3
Establishment typeManufactureManufacture Medical Device
Registered product codes
3 product codes
Recent MDR events
6,973 on file
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02705
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02706
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02395
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02627
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02513
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02632
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02636
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02640
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02571
- Eversense SensorJul 31, 2026Malfunction3009862700-2026-02643
Compliance history
Matched by FEI 3009862700.
FDA inspections
2 on file
- No Action Indicated (NAI)Nov 17, 2023
Compliance: Devices
- No Action Indicated (NAI)Nov 17, 2023
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)Oct 6, 2025
75SBA \ INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM WITH SENSOR CONTAINING DEXAMETHASONE ACETATE