EU → North America Device Access

Okolab S.r.l.

IT-MF-000045049 · Italy · Ottaviano (NA)

Okolab S.r.l. is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa39

Among these devices, 1 are declared active, 1 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 39 declared devices.

Catalogue references include H401-GLASS TABLE, H401-NIKON-SMZ25-GLASS/METAL, H401-NIKON-SMZSS-GLASS, H401-NIKON-TI-SR-METAL, H401-NIKON-TS2R-METAL, H401-OLYMPUS-IX-SUSP-T-PAD.

European nomenclature codes declared: Z120499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED39
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 GTIN39
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. Okolab S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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