EU → US Device Access

Biomedical S.r.l.

IT-MF-000027821 · Italy · Firenze

Biomedical S.r.l. is registered in the European database on medical devices as a manufacturer, with 192 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa187
Class IIb4
Class I1

Most frequent device types declared: Disposable needle for soft tissues biopsy, Disposable needle for bone biopsy, Ago monouso per agoaspirazione, Microwave thermal ablation system accessory, Disposable needle for bone marrow biopsy.

Among these devices, 188 are declared sterile, 2 active.

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 EUDAMED192
Country of registrationItaly
⚠️ 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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