EU → North America Device Access

Surgika srl

IT-MF-000024206 · Italy · Levane-Bucine (AR)

Surgika srl is registered in the European database on medical devices as a manufacturer, with 598 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa598

Most frequent device types declared: Camici chirurgici-Surgical gowns, Pacchi procedurali per Angiografia – Sterile procedural packs for Angi, Pacchi procedurali per Oftalmologia – Sterile procedural packs for Oph, Piccoli kit medicazione– Small medication and aid kits, Pinze monouso per chirurgia mini-invasiva - Single-use forceps for min.

Among these devices, 519 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 598 declared devices.

Catalogue references include C03OPH0200BZ, C06ALL0017, C06ALL0028, C08ALL1024, S05ALL0054, S05ALL1052.

European nomenclature codes declared: T0202, T0203, T020199, T020102, K01020104, T0210.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED598
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN598
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entrySURGIKA SRL

North American profile: Canada only. Surgika srl holds a Canadian licence but was not found in the U.S. register.

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