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Ansell Healthcare Europe NV

BE-MF-000000691 · Belgium · Brussels

Ansell Healthcare Europe NV is registered in the European database on medical devices as a manufacturer, with 546 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa546

Among these devices, 341 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 546 declared devices.

Catalogue references include 330104055 5.5, 340006075 7.5, 340111085 Size 8.5, 8512 6, 93244070 Size S, 93732100 Size XL.

European nomenclature codes declared: T01010102, T01020204, T01010203, T010201, T01010201, T01010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED546
Country of registrationBelgium

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

Device-level evidence

Devices with a numeric GTIN546
Found in the U.S. device database105
Share19.2 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. Ansell Healthcare Europe NV was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

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