EU → US Device Access

Serosep Limited

IE-MF-000020322 · Ireland · Limerick

Serosep Limited is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other49

Most frequent device types declared: EntericBio Workstation, EBSPSA-v2, EBCPE, EBGP2A-v3, EBFFS - GPDx.

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 EUDAMED49
Country of registrationIreland
⚠️ 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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