EU → North America Device Access

OmniMedical B.V.

NL-MF-000029303 · Netherlands · Ophemert

OmniMedical B.V. is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: Comfort Urinal, Comfort Washable bed underpads, Urinal accessories.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 20722, 20732 PC Urinal, 20741 PP, 20741 PP Urinal, 2673, 70392.

European nomenclature codes declared: U99, T04010201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN16
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. OmniMedical B.V. was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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