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Esaote S.p.A.

Italy·IT-MF-000019024

Last updated September 17, 2026

What Esaote S.p.A. makes

Esaote S.p.A. manufactures medical imaging hardware, primarily extracorporeal hand‑held ultrasound imaging transducers and radio‑frequency coils for MRI systems. Their product line includes devices such as the S‑scan MSK ReLife, MyLabX7, S‑scan Open ReLife, AC600, MyLabE850 AI, AL2442, PX 4‑13, MyLabX8 elite, MyLab 9 eHD, PX 2‑9, SL3323, and EC1123.

The portfolio spans devices classified as Class I, Class II, Class IIa, and Class III, and the devices are listed in the European EUDAMED database and the U.S. FDA 510(k) database. Esaote S.p.A. is headquartered in Italy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Esaote S.p.A. make?

Esaote S.p.A. manufactures medical imaging hardware, primarily extracorporeal hand-held ultrasound imaging transducers and radio-frequency coils for MRI systems, as stated in the provided device data.

Where is Esaote S.p.A. based?

Esaote S.p.A. is headquartered in Italy, as explicitly mentioned in the summary section of the device data.

Which registries list Esaote S.p.A.'s devices?

Esaote S.p.A.'s devices are listed in the European EUDAMED database and the U.S. FDA 510(k) database, as specified in the LISTED IN field of the device data.

How are Esaote S.p.A.'s devices classified?

Esaote S.p.A.'s devices span classifications of Class I, Class II, Class IIa, and Class III, as indicated in the DEVICE CLASSES field of the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Italy
Address: 77, Via Enrico Melen, Genova, Italy
Website: esaote.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +3901065471
PRRC Contact: Daniela Leveratto
EUDAMED SRN: IT-MF-000019024
FDA FEI Number: 3002806925
DUNS Number: —

Catalogue (290)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
MyLab AI90	100645090	EUDAMED	Class IIa	Active
MyLab300 AI	100761150	EUDAMED	Class IIa	Active
MyLab 9	100644020	EUDAMED	Class IIa	Active
MyLabX9 Pro	100644016	EUDAMED	Class IIa	Active
Ihx 6-18	120000074	EUDAMED	Class IIa	Active
G-scan Brio Premium	100002000	EUDAMED	Class IIa	Active
MyLab Class eHD	101625040	EUDAMED	Class IIa	Active
Pa250	120000032	EUDAMEDFDA UDI	Class IIa	Active
S-scan Premium	100002010	EUDAMED	Class IIa	Active
Al2445	121200700	EUDAMED	Class IIa	Active
MyLabA50 Go	100661170	EUDAMED	Class IIa	Active
MyLabE870 AI	100645089	EUDAMED	Class IIa	Active
Tmj Coil	130000027	EUDAMED	Class I	Active
Sl1543	122001200	EUDAMEDFDA UDI	Class IIa	Active
La923	9600184000	EUDAMED	Class IIa	Active
La332e	9600190000	EUDAMEDFDA UDI	Class IIa	Active
MyLabX90 eXP	100644056	EUDAMED	Class IIa	Active
MyLabE870 AI	100645092	EUDAMED	Class IIa	Active
S5mcw	121201100	EUDAMEDFDA UDI	Class IIa	Active
MyLabAlpha eHD	101740006	EUDAMED	Class IIa	Active
MyLabDesk	100210000	EUDAMED	Class IIa	Active
Te 3-8	120000118	EUDAMEDFDA UDI	Class IIa	Active
S-scan Open	100001800	EUDAMEDFDA UDI	Class IIa	Active
Pa122e	9600152000	EUDAMEDFDA UDI	Class IIa	Active
E 3-12	120000038	EUDAMEDFDA UDI	Class IIa	Active
Bl433	9600195000	EUDAMEDFDA UDI	Class IIa	Active
MyLab XPro75	100643030	EUDAMED	Class IIa	Active
L 3-15e	120000144	EUDAMEDFDA UDI	Class IIa	Active
MyLabA650 AI	100661040	EUDAMED	Class IIa	Active
MyLabOmega	101740004	EUDAMEDFDA UDI	Class IIa	Active
La522e	9600163000	EUDAMEDFDA UDI	Class IIa	Active
C 2-9	120000040	EUDAMEDFDA UDI	Class IIa	Active
MyLabX9 elite	100644061	EUDAMED	Class IIa	Active
Cx 1-8	120000100	EUDAMEDFDA UDI	Class IIa	Active
C 1-8a	120000146	EUDAMEDFDA UDI	Class IIa	Active
MyLab 7 eXP	101640003	EUDAMED	Class IIa	Active
MRI EVOlution 24	300090300	EUDAMED	Class IIa	Active
MyLab880	100645014	EUDAMED	Class IIa	Active
MyLabX7 eHD	101640031	EUDAMED	Class IIa	Active
Ca421	9600154000	EUDAMEDFDA UDI	Class IIa	Active
MyLabX8 eHD	100645020	EUDAMED	Class IIa	Active
MyLab 8 eHD	101620040	EUDAMED	Class IIa	Active
MyLabE80	100645083	EUDAMEDFDA UDI	Class IIa	Active
MRI EVOlution 25	300090700	EUDAMED	Class IIa	Active
MyLabSeven	101640000	EUDAMEDFDA UDI	Class IIa	Active
MyLabC25 Go	100761170	EUDAMED	Class IIa	Active
mC 3-11	120000046	EUDAMEDFDA UDI	Class IIa	Active
MyLab 9	100644010	EUDAMEDFDA UDI	Class IIa	Active
C 1-8e	120000120	EUDAMEDFDA UDI	Class IIa	Active
MyLabE80	100645082	EUDAMEDFDA UDI	Class IIa	Active

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