Facility

Senseonics, Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009862700
Establishment type	Manufacture Medical Device
Location	20451 Seneca Meadows Pkwy Germantown, MD, US 20876
Registration status	Active · expires 2026
Parent company	Senseonics, Inc. (owner-operator 10044307)
Brand names	Eversense NOW Application

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Continuous Glucose Monitor Secondary Display
Product code PJT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1350

Recalls & enforcement

Class IITerminated2019-09-18
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

FDA inspections (2)

NAI2023-11-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2017-01-31
No Action Indicated · Bioresearch Monitoring

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Senseonics, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Senseonics, Inc. (FEI 3009862700) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009862700-senseonics-inc/

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