EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 425 declared devices.

Catalogue references include A03180635C6R, CSSR07X90, MED NDP-08-2.0-M, MED NDP-10-1.2-M, MED NDP-20-2.0 LAP, MST-38-LL-01-080.

European nomenclature codes declared: A06010103, K01020106, G020502, A0601010402, V9011, V9099.

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

Device-level evidence

Devices with a numeric GTIN425
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. MED EUROPE EUROPEAN MEDICAL SUPPLIES SRL is registered in the United States but was not found in the Canadian register.

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

Other manufacturers in Italy

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