EU → North America Device Access

MedXPress.Pro

BE-MF-000012382 · Belgium · Leuven

MedXPress.Pro is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa16

Among these devices, 16 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include PCAG15061, PCAG15122, PCAG15244, PCAT15061, PCAT15122, PCAT15244.

European nomenclature codes declared: Z1399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDXPRESS.PRO (BE) · FDA 3017884667
Devices in EUDAMED16
Country of registrationBelgium

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: United States only. MedXPress.Pro is registered in the United States but was not found in the Canadian register.

Other manufacturers in Belgium

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