EU → US Device Access

Urifoon BV

NL-MF-000002322 · Netherlands · Amstelhoek

Urifoon BV is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: wasbaar incontinentieondergoed, model boxer voor jongens, Wasbaar incontinentie ondergoed, model heren boxer, Wasbaar incontinentie ondergoed Heupslip Dames, Wasbaar incontinentie ondergoed meisjes model hipster, Wasbaar incontinentie ondergoed, model slip meisjes.

Among these devices, 1 are declared active, 1 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationNetherlands
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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