EU → US Device Access

G. PAPANIKOLAOU & CO. LP - Bioprepare

EL-MF-000055282 · Greece · KERATEA

G. PAPANIKOLAOU & CO. LP - Bioprepare is registered in the European database on medical devices as a manufacturer, with 82 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other82

Most frequent device types declared: S.S. AGAR 050106, LEVINE EMB AGAR 010056, S.S. AGAR (BI-PLATE) 020106, MANNITOL SALT AGAR (CHAPMAN) 050068, BLOOD AGAR – CHOCOLATE AGAR 020136.

Among these devices, 82 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 EUDAMED82
Country of registrationGreece
⚠️ 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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