EU → North America Device Access

Diagam S.A.

BE-MF-000022993 · Belgium · Ghislenghien

Diagam S.A. is registered in the European database on medical devices as a manufacturer, with 959 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 959 declared devices.

Catalogue references include A1DGX-B00/COB, BUDGX-B00/ATE, CPTXL-L00/ATE, IGLCR-B00/COB, MACON-005, MGTUR-L00/ATE.

European nomenclature codes declared: W0102152003, W01021109, W0102039002, W0102010105, W0102010306, W0102010405.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDIAGAM S.A. (BE) · FDA 3003749380
Devices in EUDAMED959
Country of registrationBelgium

Device-level evidence

Devices with a numeric GTIN959
Found in the U.S. device database4
Share0.4 %

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. Diagam S.A. is registered in the United States but was not found in the Canadian register.

Other manufacturers in Belgium

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