EU → North America Device Access

Tokai Optecs NV

BE-MF-000003303 · Belgium · Tienen

Tokai Optecs NV is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa49

Most frequent device types declared: Mineral Ophthalmic Lens, Organic Bifocal Clear Lens, Organic Bifocal Ophthalmic Lens, Organic Progressive Clear Lens, Organic Progressive Ophthalmic Lens.

Devices declared under this manufacturer

Showing 12 of 49 declared devices.

European nomenclature codes declared: Q0210010101, Q0210010103, Q0210010201, Q0210010203, Q0210010102, Q0210010202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED49
Country of registrationBelgium

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN49
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. Tokai Optecs NV was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

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