EU → North America Device Access

Kay Pictures

GB-MF-000012744 · United Kingdom · Herts

Kay Pictures is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa50

Most frequent device types declared: Adjustable Flippers, Dot Cards, Eye Patches, Fixation Sticks, Magic Patch.

Authorised representative in the Union: Comply Express Lda.

Devices declared under this manufacturer

Showing 12 of 50 declared devices.

Catalogue references include FL2, FS1B, GLSJ, KFPCH, OCCLLORGN, PLANO.

European nomenclature codes declared: Z12120199, Z12120192.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED50
Country of registrationUnited Kingdom

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

Device-level evidence

Devices with a numeric GTIN50
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. Kay Pictures was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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