EU → US 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 IIa20
Class IIb14

Among these devices, 12 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED34
Country of registrationNetherlands
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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