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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 4 of 6

Device	Model / Reference	Registries	Class	Status
MyLab 7 eHD	101640004	EUDAMED	Class IIa	Active
Ec123	9600157010	EUDAMED	Class IIa	Active
Sl3332	122001300	EUDAMEDFDA UDI	Class IIa	Active
Px 1-5b	120000078	EUDAMED	Class IIa	Active
MyLabE	100645080	EUDAMED	Class IIa	Active
P2 5-13	120000044	EUDAMED	Class IIa	Active
La523e	9600174000	EUDAMEDFDA UDI	Class IIa	Active
Cervical Coil N.14	9103531000	EUDAMEDFDA UDI	Class I	Active
MyLabEight eXP	101620030	EUDAMEDFDA UDI	Class IIa	Active
Bc431	9600183000	EUDAMEDFDA UDI	Class IIa	Active
MyLab250 AI	100761130	EUDAMED	Class IIa	Active
MyLabE85	100645084	EUDAMEDFDA UDI	Class IIa	Active
Ca431	9600177000	EUDAMEDFDA UDI	Class IIa	Active
C 1-8	120000013	EUDAMEDFDA UDI	Class IIa	Active
Ihx 6-25	120000137	EUDAMEDFDA UDI	Class IIa	Active
Ca123	9600158000	EUDAMEDFDA UDI	Class IIa	Active
MyLabC	100760000	EUDAMED	Class IIa	Active
MyLabX75 eXP	100643021	EUDAMED	Class IIa	Active
P 2-9	120000039	EUDAMEDFDA UDI	Class IIa	Active
Sl3235	122000600	EUDAMEDFDA UDI	Class IIa	Active
MyLabE8	100645012	EUDAMED	Class IIa	Active
E-MRI Brio Viewer eXP	100201000	EUDAMED	Class IIa	Active
S2mpw	121202100	EUDAMEDFDA UDI	Class IIa	Active
Ca133	9600172000	EUDAMED	Class IIa	Active
MyLabA60	100661010	EUDAMED	Class IIa	Active
MyLab AI200	100761140	EUDAMED	Class IIa	Active
Lp 4-13	120000026	EUDAMEDFDA UDI	Class IIa	Active
5cwl	120000107	EUDAMEDFDA UDI	Class IIa	Active
Ca1123	122000800	EUDAMEDFDA UDI	Class IIa	Active
Be1123	411403	EUDAMEDFDA UDI	Class IIa	Active
MyLabA750 AI	100661050	EUDAMED	Class IIa	Active
Se3133	1210000034	EUDAMED	Class IIa	Active
Ca621	9600155000	EUDAMEDFDA UDI	Class IIa	Active
MyLabX5	102642004	EUDAMEDFDA UDI	Class IIa	Active
L 3-11	120000014	EUDAMEDFDA UDI	Class IIa	Active
MyLab XPro80	100645030	EUDAMED	Class IIa	Active
MyLab Class eXP	101625050	EUDAMED	Class IIa	Active
MyLabE850 AI	100645086	EUDAMED	Class IIa	Active
Sp2442	121200600	EUDAMEDFDA UDI	Class IIa	Active
Lmx 4-20	120000101	EUDAMEDFDA UDI	Class IIa	Active
MyLabClass C Advanced	101620020	EUDAMEDFDA UDI	Class IIa	Active
MyLabA50	100661000	EUDAMEDFDA UDI	Class IIa	Active
Xl Spine Coil 10	130000016	EUDAMEDFDA UDI	Class I	Active
P2 3-11	120000035	EUDAMEDFDA UDI	Class IIa	Active
MyLabX75 eHD	100643020	EUDAMEDFDA UDI	Class IIa	Active
Sp2430	121200100	EUDAMEDFDA UDI	Class IIa	Active
Tee132	9600186100	EUDAMEDFDA UDI	Class IIa	Active
MyLabX90 eXP	100644052	EUDAMED	Class IIa	Active
L 4-15	120000036	EUDAMEDFDA UDI	Class IIa	Active
MyLabA50 Go	100661070	EUDAMED	Class IIa	Active

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