EU → North America Device Access

Zeta S.r.l. - MF

IT-MF-000017619 · Italy · Napoli

Zeta S.r.l. - MF is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa27

Most frequent device types declared: Heat Patch Skin Adhesive SP 586, Hot &Cold, Medical Heat Belt, WBS Blanket.

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Showing 12 of 27 declared devices.

Catalogue references include 2350071, 2350080, 7000003005Z, 7000003006Z, WBS0003, ZET-GS001.

European nomenclature codes declared: M9001, T030399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED27
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 GTIN27
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: Neither register. Zeta S.r.l. - MF was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
IT346520issued2030-10-12

Other manufacturers in Italy

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