EU → North America Device Access

PRANARÔM ESPAÑA S.L.U

ES-MF-000014215 · Spain · Barcelona

PRANARÔM ESPAÑA S.L.U is registered in the European database on medical devices as a manufacturer, with 45 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa45

Most frequent device types declared: 11359, 13151, 2096, PT2096, SPRAYG1.

Devices declared under this manufacturer

Showing 12 of 45 declared devices.

Catalogue references include 13151, 17592, 21193, 21730, 22713, 22884.

European nomenclature codes declared: Q030103, V9017.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED45
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 GTIN37
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. PRANARÔM ESPAÑA S.L.U was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
103/MDRsupplemented2028-06-13

Other manufacturers in Spain

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