EU → US Device Access

Momina krepost PLC

BG-MF-000019803 · Bulgaria · Veliko Tarnovo

Momina krepost PLC is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa35

Most frequent device types declared: With slit, Dark Blue, Without slit, Dark Blue, No additional ties, Dark Blue, With additional ties, Dark Blue, No additional ties, Dark blue.

Among these devices, 34 are declared sterile, 2 with a measuring function.

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 EUDAMED35
Country of registrationBulgaria
⚠️ 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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