EU → US Device Access

SIDAPHARM Private Company

GR-MF-000016490 · Greece · Thessaloniki

SIDAPHARM Private Company is registered in the European database on medical devices as a manufacturer, with 235 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb233
Class IIa2

Most frequent device types declared: SDHB6130i, SDHBi, SDHB6130Si, 77007, 77006.

Among these devices, 235 are declared sterile, 233 implantable.

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 EUDAMED235
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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