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SENSEONICS, INCORPORATED

Last updated May 24, 2026

Information

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Eversense® Mobile App iOS	FG-5501-01-300	FDA UDI	Class III	Unknown
Sensoronics	SBPM-50	FDA UDI	Class II	Active
Sensoronics	SRP-OHM-3P	FDA UDI	Class II	Active
Sensoronics	SRP-BCI-3P	FDA UDI	Class II	Active
Eversense Mobile App Android	FG-5502-02-300	FDA UDI	Class III	Active
Sensoronics	SC-PHOXNE-8RH	FDA UDI	Class II	Active
Eversense® Smart Transmsitter Kit - Retail	FG-3301-01-001	FDA UDI	Class III	Unknown
Sensoronics	SRP-NCRO-9A	FDA UDI	Class II	Active
Sensoronics	SECG-GE12L-TC	FDA UDI	Class II	Active
Sensoronics	SC-GEOH-8	FDA UDI	Class II	Active
Eversense® DMS	FG-5700-01-300	FDA UDI	Class I	Unknown
Sensoronics	SRP-NON-3A	FDA UDI	Class II	Active
Eversense E3 Sensor Kit - DME	FG-7200-00-301	FDA UDI	Class III	Active
Sensoronics	SPO50	FDA UDI	Class II	Active
Sensoronics	SRP-NCRO-3A	FDA UDI	Class II	Active
Sensoronics	SECG-PHP3L-1605	FDA UDI	Class II	Active
Eversense E3 Insertion Tools Kit	FG-8300-01-201	FDA UDI	Class III	Active
Sensoronics	SC-OXNE-4	FDA UDI	Class II	Active
Sensoronics	SFP-NCR-18A Oximax	FDA UDI	Class II	Active
Eversense® Sensor Kit - Retail	FG-4201-00-301	FDA UDI	Class III	Unknown
Eversense E3 Smart Transmitter Kit - Provider Purchase	FG-5902-01-001	FDA UDI	Class III	Active
Eversense AP CGM System	DEN230052	FDA 510(k)	Class II	Active
Eversense 365 Continuous Glucose Monitoring (CGM) System	K241335	FDA 510(k)	Class II	Active
Eversense Continuous Glucose Monitoring System	P160048	FDA PMA	Class III	Active

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