EU → North America Device Access

Ivalmed S.L.

ES-MF-000000634 · Spain · Paterna, Valencia

Ivalmed S.L. is registered in the European database on medical devices as a manufacturer, with 4 138 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa4 138

Among these devices, 4 138 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 4 138 declared devices.

Catalogue references include IV700-28, IV702-62-03, IV702-76-01, IV703-80-01, IV780-60-10, IV788-56-05.

European nomenclature codes declared: L0399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED4 138
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 GTIN4 138
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. Ivalmed S.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ES26/00000408issued2031-03-30

Other manufacturers in Spain

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