EU → North America 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

Most frequent device types declared: ANAEROBE CDC – ANAEROBE CNA – BACTEROIDES BILE ESCULINE AGAR (BBE) 03, BLOOD AGAR (HORSE BLOOD) (BI-PLATE) 020012, BLOOD AGAR (SHEEP BLOOD) 010011 / 050011, BLOOD AGAR – CHOCOLATE AGAR 020136, CLED AGAR 010034.

Among these devices, 82 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 82 declared devices.

Catalogue references include 010011 / 050011, 010056, 020106, 020136, 020847, 030151.

European nomenclature codes declared: W0104010405, W0104010499, W0104010404, W0104050199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED82
Country of registrationGreece

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN82
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. G. PAPANIKOLAOU & CO. LP - Bioprepare was not found in either the U.S. or the Canadian register.

Other manufacturers in Greece

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