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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 1 of 6

Device	Model / Reference	Registries	Class	Status
S-scan MSK ReLife	100001840	EUDAMED	Class IIa	Active
MyLabX7	101640030	EUDAMED	Class IIa	Active
S-scan Open ReLife	100001830	EUDAMED	Class IIa	Active
Ac600	101640009	EUDAMED	Class IIa	Active
MyLabE850 AI	100645087	EUDAMED	Class IIa	Active
Al2442	121200300	EUDAMEDFDA UDI	Class IIa	Active
Px 4-13	120000207	EUDAMED	Class IIa	Active
MyLabX8 elite	100645022	EUDAMED	Class IIa	Active
MyLab 9 eHD	100644030	EUDAMED	Class IIa	Active
Px 2-9	120000148	EUDAMED	Class IIa	Active
Sl3323	122000200	EUDAMEDFDA UDI	Class IIa	Active
Ec1123	411312	EUDAMEDFDA UDI	Class IIa	Active
MyLabX9 Plus	100644063	EUDAMED	Class IIa	Active
MyLabOmega eXP	101740044	EUDAMED	Class IIa	Active
MyLab250 XV	101740042	EUDAMED	Class IIa	Active
La435	9600173000	EUDAMEDFDA UDI	Class IIa	Active
Ih 6-18	120000023	EUDAMEDFDA UDI	Class IIa	Active
MyLabA80 AI	100661160	EUDAMED	Class IIa	Active
MyLabX90 Plus	100640086	EUDAMED	Class IIa	Active
Lp323	9600162000	EUDAMEDFDA UDI	Class IIa	Active
MyLab 9 elite	100644021	EUDAMED	Class IIa	Active
Lumbar Coil N.17	131000200	EUDAMEDFDA UDI	Class I	Active
Ca430e	9600169000	EUDAMEDFDA UDI	Class IIa	Active
Ioe323	9600160000	EUDAMEDFDA UDI	Class IIa	Active
Shfcw	121201200	EUDAMEDFDA UDI	Class IIa	Active
P 1-5a	120000145	EUDAMEDFDA UDI	Class IIa	Active
Tlc 3-13	120000025	EUDAMEDFDA UDI	Class IIa	Active
2cwl	120000106	EUDAMEDFDA UDI	Class IIa	Active
MyLabEight	101625030	EUDAMEDFDA UDI	Class IIa	Active
Mylabseven, Mylabalpha	K111302	FDA 510(k)	Class II	Active
G-Scan-Model 9800020000, E-Scan Model 9800010000 And E-Scan Xq-Models-9800010011/9800010005, 9800010009/9800010004	K060956	FDA 510(k)	Class II	Active
Modification To E-Scan Xq Mri System	K041145	FDA 510(k)	Class II	Active
Mylab30, 50 And 70 Systems Upgrade, Models 7300, 7350, 6150	K052805	FDA 510(k)	Class II	Active
S-Scan, Model 9800020010	K100670	FDA 510(k)	Class II	Active
6440 Ultrasound System	K173291	FDA 510(k)	Class II	Active
6200 / 6250 Ultrasound System	K133905	FDA 510(k)	Class II	Active
O-Scan Mr System	K092469	FDA 510(k)	Class II	Active
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)	K243253	FDA 510(k)	Class II	Active
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)	K253310	FDA 510(k)	Class II	Active
G-Scan Cervical Spine Coil	K052077	FDA 510(k)	Class II	Active
Mylabseven 6400, Mylabalpha 7400	K132466	FDA 510(k)	Class II	Active
Mylabtwice, Model 6200	K100931	FDA 510(k)	Class II	Active
7350 Ultrasound Imaging System, Model 7350	K050326	FDA 510(k)	Class II	Active
6430 MyLabX75, 6430 MyLab XPro75	K212021	FDA 510(k)	Class II	Active
Mylab30, 50, 70 And 90 Systems Addition Of 3d/4d, Models 7300, 7350, 6150, 6100	K060827	FDA 510(k)	Class II	Active
6450 Ultrasound system	K192157	FDA 510(k)	Class II	Active
Mylabgamma	K142077	FDA 510(k)	Class II	Active
Orthocad Software Option	K120288	FDA 510(k)	Class II	Active
My Labs25 Gold/Mylab30 Gold Cardiovascular Model 7340, My Lab70/My Lab70xvision/Mylab60, Model 6150	K091009	FDA 510(k)	Class II	Active
Speedup Software Option	K120748	FDA 510(k)	Class II	Active

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