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Etnia Eyewear Culture S.L

ES-MF-000035523 · Spain · Barcelona

Etnia Eyewear Culture S.L is registered in the European database on medical devices as a manufacturer, with 2 135 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 135

Most frequent device types declared: 4 SORA 53O BKHV.

Devices declared under this manufacturer

Showing 12 of 2 135 declared devices.

Catalogue references include 4 BELA 52O BXPK, 5 ASTERI 52O PU, 5 ATLAS 57O GRHO, 5 PANDA 45O WHPU, 5 STELE 56O HV, 6 ALTAIR 54O DBGR.

European nomenclature codes declared: Q02100299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 135
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 GTIN2 135
Found in the U.S. device database1 103
Share51.7 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. Etnia Eyewear Culture S.L was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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