EU → US Device Access

IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.

GR-MF-000032958 · Greece · Athens

IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa73
Class IIb5

Most frequent device types declared: UNISEPT IMPLANTS MOUTHWASH 1.5L, SELVA BABY CARE 150mL, SELVA AROMATIC 50mL, HY+AL GEL 12g, UNISEPT OTIC DROPS 10mL.

Among these devices, 7 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 EUDAMED78
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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