EU → North America Device Access

Optika Microscopes

IT-MF-000042742 · Italy · Ponteranica (BG)

Optika Microscopes is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: B-1000, B-150, B-380, B-60, IM-300.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include B-1000.XXXX, B-150.XXXX, B-60.XXXX, IM-300.XXXX, IM-5.XXXX, SFX.XXXX.

European nomenclature codes declared: W0202050303.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
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 GTIN16
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. Optika Microscopes was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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