EU → North America Device Access

SOPLAST EMILIANA S.r.l.

IT-MF-000025628 · Italy · FIDENZA (PR)

SOPLAST EMILIANA S.r.l. is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include 201, 231, 250, 301, 550, 610.

European nomenclature codes declared: R03010380, Q030199, A0799, A0399, Q030399, U0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
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 GTIN28
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. SOPLAST EMILIANA S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
62182issued2031-01-20

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