EU → North America Device Access

AYALA SAMPLE KITS, S.L.

ES-MF-000037853 · Spain · Castellón de la Plana

AYALA SAMPLE KITS, S.L. is registered in the European database on medical devices as a manufacturer, with 95 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: 7ATFRU, 7ATLAC, 7ATSAC, 7SIBOGLU, 7SIBOLOL, 7ATSOR, 8ATFRU, 8ATLAC, 8A, ADNTRO-S-01, CAL002, CAL005, CAL006.1, CAL003, CAL003.1, CAL003.2, CAL003.3, CAL003.4, CAL003.5, CAL003.6, CA, CAL004.1, CAL011.01, CAL011.02, CAL011.03, CAL011.04, CAL011.05, CAL01.

Devices declared under this manufacturer

Showing 12 of 95 declared devices.

Catalogue references include 210SIBOLOL, 8SIBOLSA, CAL003.14, CAL003.6, CAL003.8, CAL011.07.

European nomenclature codes declared: W05019099, W0503010101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED95
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 GTIN95
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. AYALA SAMPLE KITS, S.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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