EU → North America Device Access

Sundial Co. Ltd

CY-MF-000023765 · Cyprus · lemesos

Sundial Co. Ltd is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Among these devices, 58 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 60 declared devices.

Catalogue references include SUN15300, SUN90050, SUN90100, SUN90130, SUN90140, SUN90200.

European nomenclature codes declared: W0104010405, W0104010206, W0104010407, W0104010403, W0104010402, W0104010306.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED60
Country of registrationCyprus

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

Device-level evidence

Devices with a numeric GTIN60
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. Sundial Co. Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in Cyprus

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