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DIAGNOSYS LLC

United States·US-MF-000002934

Last updated September 17, 2026

Information

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Espion	D310	FDA UDI	Class II	Active
Espion	D315	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D315	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D315	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D315	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D310	FDA UDI	Class II	Active
Espion	D315	FDA UDI	Class II	Active
E3 and Profile	K221471	FDA 510(k)	Class II	Active
DTL Plus Electrodes	D141	EUDAMEDFDA UDI	Class IIa	Active
ColorDome	D125	EUDAMEDFDA UDI	Class IIa	Active
PSG Pattern Stimulator:	D217	EUDAMED	Class IIa	Active
Attache	D341	EUDAMEDFDA UDI	Class IIa	Active
ColorFlash	D382	EUDAMEDFDA UDI	Class IIa	Active
MaculoScope	D130	EUDAMED	Class IIa	Active
ColorBurst	D213	EUDAMEDFDA UDI	Class IIa	Active
Profile	D310	EUDAMEDFDA UDI	Class IIa	Active
Envoy	D352	EUDAMEDFDA UDI	Class IIa	Active
E3	D315	EUDAMEDFDA UDI	Class IIa	Active
Eer	D366	EUDAMEDFDA UDI	Class IIa	Active
Standalone	D175	EUDAMEDFDA UDI	Class IIa	Active

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