EU → North America Device Access

CLINI-LAB SRL

IT-MF-000007798 · Italy · CONSELVE (PD)

CLINI-LAB SRL is registered in the European database on medical devices as a manufacturer, with 81 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa81

Most frequent device types declared: 35906.1S.

Among these devices, 70 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 81 declared devices.

Catalogue references include 013061XL, 013092XS, 013151L, 013151XS, 013152.S, 013152L.

European nomenclature codes declared: T01020204, T01020201, T010201, A06030301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED81
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 GTIN81
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. CLINI-LAB SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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