EU → North America Device Access

ASSUT EUROPE SPA

IT-MF-000018178 · Italy · Rome

ASSUT EUROPE SPA is registered in the European database on medical devices as a manufacturer, with 5 673 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class I5 673

Among these devices, 5 673 are declared sterile, 5 673 implantable.

Devices declared under this manufacturer

Showing 12 of 5 673 declared devices.

Catalogue references include 10FSPAH, AM0208BR, FR249HHFAQ, FS407HHAB, FS423HHFST, FS979HHAH.

European nomenclature codes declared: H010101020101, H010101010104, H010101020201,H010101020202,H010101020203, H010101010301, H010101010303, H010101010101.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryAssut Europe S.P.A. (IT) · FDA 9617547
Devices in EUDAMED5 673
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN5 673
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.

Notified body certificates

CertificateStatusExpiry
CVD0060260126issued2028-08-07
CVD0051260326supplemented2028-08-07
CVD0050250126supplemented2028-08-07
CVD0049250126supplemented2028-08-07
CVD0048250326supplemented2028-08-07
CVD004725issued2028-08-07
CVD0044250226supplemented2028-08-07
CVD0041240324supplemented2028-08-07

Other manufacturers in Italy

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