EU → US Device Access

PRODCONFARM SRL

RO-MF-000017975 · Romania · PITESTI

PRODCONFARM SRL is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: STERILE GAUZE COMPRESSES 7.5 cm / 7.5 cm, STERILE GAUZE COMPRESSES FOLDED 10cm/10cm*8str*5buc, STERILE GAUZE COMPRESSES 20 cm / 20 cm, STERILE GAUZE COMPRESSES 5cm/5cm, STERILE GAUZE COMPRESSES 10 cm / 20 cm.

Among these devices, 14 are declared sterile.

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 EUDAMED28
Country of registrationRomania
⚠️ 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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