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Esaote S.p.A.

Manufacturer of medical devices registered in the European database in Genova, Italy.

Registration number (SRN)IT-MF-000019024
RoleManufacturer
StatusActive
CountryItaly
City16152 Genova
AddressVia Enrico Melen, 77 16152 Genova
Registered on2022-01-14

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryESAOTE S.P.A. (IT) · FDA 8043485

Notified body certificates

CertificateStatusExpiryTypeBody
G15 095545 0032reissued2031-08-24Quality management systemNB 0123
G10 095545 0024validexpired 2026-08-24Quality management systemNB 0123

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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