EU → North America Device Access

Lopital Nederland B.V.

NL-MF-000004372 · Netherlands · Oisterwijk

Lopital Nederland B.V. is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa36

Most frequent device types declared: 51005199, 51005300, 51005750, 54006021, 59008200.

Among these devices, 9 are declared active.

Devices declared under this manufacturer

Showing 12 of 36 declared devices.

Catalogue references include 51005199, 51005300, 51005750, 54006021, 59008200, 59008250.

European nomenclature codes declared: Y091203, Y093399, Y093312, V080702, Y050201.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLOPITAL NEDERLAND B.V. (NL) · FDA 3007238754
Devices in EUDAMED36
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN36
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: United States only. Lopital Nederland B.V. is registered in the United States but was not found in the Canadian register.

Other manufacturers in Netherlands

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