EU → US Device Access

PentaBase A/S

DK-MF-000023157 · Denmark · Odense

PentaBase A/S is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other33

Most frequent device types declared: Sensitive Nucleic Acid Purification Kit, RT-qPCR Assay, BRAF qPCR Assay, PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay, EGFR qPCR Assay.

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 EUDAMED33
Country of registrationDenmark
⚠️ 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.

Other manufacturers in Denmark

All Denmark manufacturers →