EU → US Device Access

Dr Irena Eris S.A.

PL-MF-000026938 · Poland · Piaseczno

Dr Irena Eris S.A. is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Most frequent device types declared: Emotopic Emulsja do kąpieli MED+ do codziennego stosowania, Emotopic Bacteria Control KREM MEDICAL do twarzy i okolic oczu, Emotopic Bacteria Control BALSAM MEDICAL do ciała , Emotopic Łagodzący krem na egzemę MED+ do twarzy i ciała, Emotopic Bacteria Control PREPARAT S.O.S. MEDICAL do twarzy i ciała.

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 EUDAMED17
Country of registrationPoland
⚠️ 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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