EU → North America 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 Bacteria Control BALSAM MEDICAL do ciała, Emotopic Bacteria Control KREM MEDICAL do twarzy i okolic oczu, Emotopic Bacteria Control MICELARNA EMULSJA MYJĄCA MEDICAL do twarzy , Emotopic Bacteria Control PREPARAT S.O.S. MEDICAL do twarzy i ciała, Emotopic Emulsja do kąpieli MED+ do codziennego stosowania.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 10M1478-01-01, 10M16007-01-03 (90MM16007A), 10M16923-01-01, 10M16924-01-01, 10M16925-01-01, 10M16928-01-01.

European nomenclature codes declared: M9002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
Country of registrationPoland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN17
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Dr Irena Eris S.A. was not found in either the U.S. or the Canadian register.

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