EU → North America Device Access

Bfactory Health Products B.V.

NL-MF-000021590 · Netherlands · Rhenen

Bfactory Health Products B.V. is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb14
Class IIa20

Among these devices, 12 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 34 declared devices.

Catalogue references include 10010, 10380, 11040, 20300, 20466, 20650.

European nomenclature codes declared: M0499, M04040701.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED34
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN34
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: Neither register. Bfactory Health Products B.V. was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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