EU → US Device Access

RESTECH SRL

IT-MF-000026505 · Italy · MILANO

RESTECH SRL is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Most frequent device types declared: Resmon PRO FULL, Resmon PRO DIARY, Resolve.

Among these devices, 4 are declared active, 4 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryRESTECH SRL (IT) · FDA 3012624216
Devices in EUDAMED5
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
139/MDRsupplemented2028-11-19

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