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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 5 of 6

Device	Model / Reference	Registries	Class	Status
Tmj Coil 19	130000006	EUDAMEDFDA UDI	Class I	Active
MyLabA500 AI	100661130	EUDAMED	Class IIa	Active
MyLabX7 eXP	101640032	EUDAMED	Class IIa	Active
Ca631	9600185000	EUDAMEDFDA UDI	Class IIa	Active
Sp3630	122001400	EUDAMEDFDA UDI	Class IIa	Active
Trt33	9600175000	EUDAMEDFDA UDI	Class IIa	Active
MyLabC25	100761100	EUDAMED	Class IIa	Active
L 8-24	120000041	EUDAMED	Class IIa	Active
Cervical Coil N.9	9102693100	EUDAMED	Class I	Active
Pa023e	9600153000	EUDAMEDFDA UDI	Class IIa	Active
MyLabE85	100645085	EUDAMEDFDA UDI	Class IIa	Active
G-scan Brio	101002000	EUDAMEDFDA UDI	Class IIa	Active
Sb3123	122001900	EUDAMEDFDA UDI	Class IIa	Active
Tee122	9600186000	EUDAMEDFDA UDI	Class IIa	Active
MyLabX8 Pro	100645023	EUDAMED	Class IIa	Active
Tee022	9600170000	EUDAMEDFDA UDI	Class IIa	Active
Iot332	121011100	EUDAMEDFDA UDI	Class IIa	Active
MyLabX8 eXP	100645010	EUDAMEDFDA UDI	Class IIa	Active
P 5-13	120000022	EUDAMED	Class IIa	Active
MyLabE880 AI	100645094	EUDAMED	Class IIa	Active
I-Genius	100019400	EUDAMED	Class IIa	Active
MyLabTwice	101620000	EUDAMEDFDA UDI	Class IIa	Active
Px 1-5	120000066	EUDAMEDFDA UDI	Class IIa	Active
MyLabX9	100644015	EUDAMEDFDA UDI	Class IIa	Active
La424	9600149000	EUDAMED	Class IIa	Active
Pa121e	9600151000	EUDAMEDFDA UDI	Class IIa	Active
MyLab 8 eXP	101620050	EUDAMED	Class IIa	Active
Ac2541	121200500	EUDAMEDFDA UDI	Class IIa	Active
Pa230e	9600165000	EUDAMEDFDA UDI	Class IIa	Active
Bl433	9600195010	EUDAMED	Class IIa	Active
Sl3116	122000100	EUDAMEDFDA UDI	Class IIa	Active
MyLabX6	101640006	EUDAMEDFDA UDI	Class IIa	Active
Ca541	121010900	EUDAMEDFDA UDI	Class IIa	Active
Si2c41	121201800	EUDAMEDFDA UDI	Class IIa	Active
P 1-5e	120000119	EUDAMEDFDA UDI	Class IIa	Active
Ac750	100643009	EUDAMED	Class IIa	Active
Lmx 3-16	120000176	EUDAMED	Class IIa	Active
La532e	9600168000	EUDAMEDFDA UDI	Class IIa	Active
MyLabA80 AI	100661060	EUDAMED	Class IIa	Active
La523	9600156000	EUDAMEDFDA UDI	Class IIa	Active
Magnifico MSK	100009910	EUDAMEDFDA UDI	Class IIa	Active
Al300	101741009	EUDAMED	Class IIa	Active
MyLabE8 eXP	100645013	EUDAMED	Class IIa	Active
MyLabX9 Pro	100644062	EUDAMED	Class IIa	Active
MyLab 9 eXP	100644000	EUDAMEDFDA UDI	Class IIa	Active
Magnifico Open	100009900	EUDAMEDFDA UDI	Class IIa	Active
G-scan Open	100001700	EUDAMEDFDA UDI	Class IIa	Active
La533	122001100	EUDAMEDFDA UDI	Class IIa	Active
MyLabClass C	101625000	EUDAMEDFDA UDI	Class IIa	Active
MyLabE800 AI	100645095	EUDAMED	Class IIa	Active

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