EU → North America Device Access

CONÓPTICA, S.L.

ES-MF-000040465 · Spain · CORNELLÀ DE LLOBREGAT

CONÓPTICA, S.L. is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: BIMO, BS, EPMO, K3MO, K3MU.

Catalogue references include RGP.

European nomenclature codes declared: Q02100499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN11
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. CONÓPTICA, S.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2025 PR 0060issued2030-09-22

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