EU → US Device Access

BIOPSYBELL SRL

IT-MF-000011601 · Italy · mirandola

BIOPSYBELL SRL is registered in the European database on medical devices as a manufacturer, with 3 231 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa3 231

Most frequent device types declared: RTI-MIS, VKFU-1517-AMS, KMVT1315001C-A, RESWTR0812C, RES1212002V.

Among these devices, 3 231 are declared sterile, 748 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 registerSimilar name found — unverified
Matched entryBIOPSYBELL S.R.L. (IT) · FDA 9617616
Devices in EUDAMED3 231
Country of registrationItaly
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
IT349638issued2030-02-09

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