EU → US Device Access

Bio3 Implants GmbH

DE-MF-000009538 · Germany · Pforzheim

Bio3 Implants GmbH is registered in the European database on medical devices as a manufacturer, with 358 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa221
Class IIb137

Most frequent device types declared: Non-Sterile Dental Suprastructures, Non-Sterile Dental Abutments, Wrench and screw tools, Stopper tools, Dental Implant Progressive.

Among these devices, 38 are declared sterile, 137 implantable.

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 EUDAMED358
Country of registrationGermany
⚠️ 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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