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Esaote S.p.A.

Italy·IT-MF-000019024

Last updated September 17, 2026

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 2 of 6

Device	Model / Reference	Registries	Class	Status
7410 Ultrasound System (MyLabSigma)	K191072	FDA 510(k)	Class II	Active
A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18	K110802	FDA 510(k)	Class II	Active
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)	K241671	FDA 510(k)	Class II	Active
Mylab 70 Ultrasound Imaging System	K051308	FDA 510(k)	Class II	Active
6400 Ultrasound System, 7400 Ultrasound System, 7410 Ultrasound System	K161359	FDA 510(k)	Class II	Active
Ultrasound Imaging System, Model 7300	K040596	FDA 510(k)	Class II	Active
Artoscan C	K040877	FDA 510(k)	Class II	Active
S-Scan Mri System	K063207	FDA 510(k)	Class II	Active
Temporomanibular Coil 15	K110373	FDA 510(k)	Class II	Active
Model 6150 (mylab70) And Model 6100 (mylab90)	K081386	FDA 510(k)	Class II	Active
Magnifico Open, Magnifico MSK	K212419	FDA 510(k)	Class II	Active
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)	K253288	FDA 510(k)	Class II	Active
Mylabseven, Mylabalpha	K142008	FDA 510(k)	Class II	Active
Mylabssogno	K140677	FDA 510(k)	Class II	Active
Mylabseven, Mylabalpha	K132231	FDA 510(k)	Class II	Active
Mylab30, Model 7300	K071996	FDA 510(k)	Class II	Active
MRI Dynamic Analysis Plus	K153039	FDA 510(k)	Class II	Active
MyLabSix CrystaLine	K162290	FDA 510(k)	Class II	Active
Model 7340 Ultrasound System	K081794	FDA 510(k)	Class II	Active
Mylab 90 Ultrasound Imaging System, Model 6100	K051837	FDA 510(k)	Class II	Active
6400 Ultrasound System (MyLabX6, MyLabX7)	K190989	FDA 510(k)	Class II	Active
6420 Ultrasound System	K183191	FDA 510(k)	Class II	Active
6250 Ultrasound Sytems	K103152	FDA 510(k)	Class II	Active
Modification To E-Scan Xq	K032121	FDA 510(k)	Class II	Active
Mylabsogno	K121384	FDA 510(k)	Class II	Active
Magnifico Open (100009900); Magnifico MSK ( 100009910)	K241133	FDA 510(k)	Class II	Active
6200 Ultrasound System and 6250 Ultrasound System	K163082	FDA 510(k)	Class II	Active
Dynamic Mri Software Option For C-Scan, E-Scan Xq And E-Scan Opera	K061429	FDA 510(k)	Class II	Active
S-Scan, G-Scan, Dynamic Mri Software For C-Scan, E-Scanxq & E-Scan Opera	K080968	FDA 510(k)	Class II	Active
6200 Ultrasound System and 6250 Ultrasound System	K153277	FDA 510(k)	Class II	Active
MyLabX90 eHD	100644053	EUDAMED	Class IIa	Active
Sp2730	121202200	EUDAMEDFDA UDI	Class IIa	Active
2cws	120000103	EUDAMEDFDA UDI	Class IIa	Active
MyLab AI850	100645099	EUDAMED	Class IIa	Active
5cws	120000104	EUDAMEDFDA UDI	Class IIa	Active
MyLabOmegaX	101740032	EUDAMED	Class IIa	Active
MyLabA50	100661100	EUDAMEDFDA UDI	Class IIa	Active
St2612	121200801	EUDAMEDFDA UDI	Class IIa	Active
Hip Coil N.11	130000028	EUDAMED	Class I	Active
Tmj Coil 19	130000005	EUDAMEDFDA UDI	Class I	Active
MyLabX90	100644050	EUDAMEDFDA UDI	Class IIa	Active
MyLabE870 AI	100645088	EUDAMED	Class IIa	Active
MyLabC30	100761120	EUDAMED	Class IIa	Active
Il 4-13	120000027	EUDAMEDFDA UDI	Class IIa	Active
P 1-5	120000015	EUDAMEDFDA UDI	Class IIa	Active
mCX 3-12	120000149	EUDAMED	Class IIa	Active
MyLab AI300	100761160	EUDAMED	Class IIa	Active
MyLabOmega	101740030	EUDAMED	Class IIa	Active
MyLab300 XV	101740043	EUDAMED	Class IIa	Active
MyLabX90 elite	100644084	EUDAMED	Class IIa	Active

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