EU → US Device Access

MED EUROPE EUROPEAN MEDICAL SUPPLIES SRL

IT-MF-000026962 · Italy · BOLOGNA

MED EUROPE EUROPEAN MEDICAL SUPPLIES SRL is registered in the European database on medical devices as a manufacturer, with 425 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa408
Class IIb17

Most frequent device types declared: SMALL .

Among these devices, 399 are declared sterile, 6 implantable, 3 reusable.

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 entryMED EUROPE EUROPEAN MEDICAL SUPPLIES Srl (IT) · FDA 3003826419
Devices in EUDAMED425
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
ITI 2522914 1issued2031-07-14
ITH 2522914 1issued2031-07-14
0425-MDR-030102-01amended2029-10-17
0425-MDR-030029-02issued2028-05-11
0425-MDR-030028-02issued2028-05-11

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