EU → North America Device Access

Nea International

NL-MF-000006631 · Netherlands · Maastricht-Airport

Nea International is registered in the European database on medical devices as a manufacturer, with 109 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa109

Devices declared under this manufacturer

Showing 12 of 109 declared devices.

Catalogue references include 1.30.2.01, 1.40.1.03, 2.10.2.14, 2.10.2.22, 2.20.4.14, 2.20.4.21.

European nomenclature codes declared: Y06120601, Y060609, Y060499, Y061209, Y060603, Y060621.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNEA INTERNATIONAL BV (NL) · FDA 9614578
Devices in EUDAMED109
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN109
Found in the U.S. device database101
Share92.7 %

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. Nea International is registered in the United States but was not found in the Canadian register.

Other manufacturers in Netherlands

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