FDA Device Entity Profile: ESAOTE S.P.A.

Known Identifiers & Locations

FEI Numbers 1826555, 3002806925, 3002806926, 3012981490, 3012987001, 3013839079

Owner Operator Numbers 8021005

Locations Covered FLORENCE Firenze, IT; Fishers, IN, US; GENOVA Liguria, IT; GM Sittard Limburg, NL; Genova, IT; Sesto Fiorentino Firenze, IT

Registered Establishments (6)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1826555	Esaote North America, Inc	Fishers, IN, US	Complaint File Establishment per 21 CFR 820.198	View Details
3012981490	ESAOTE S.P.A.	Sesto Fiorentino Firenze, IT	Manufacture Medical Device	View Details
3012987001	Proton B.V.	GM Sittard Limburg, NL	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3013839079	EBIT S.r.l.	Genova, IT	Manufacture Medical Device	View Details
8043485	ESAOTE S.P.A.	GENOVA Liguria, IT	Manufacture Medical Device	View Details
9611125	ESAOTE S.P.A.	FLORENCE Firenze, IT	Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K110373	TEMPOROMANIBULAR COIL 15	2011-04-06	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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