EU → North America Device Access

DGA Optima Robert John

PL-MF-000047744 · Poland · Toruń

DGA Optima Robert John is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Catalogue references include 22901, 22902, 22903, 22904, 25901, PSM10-5050.

European nomenclature codes declared: T030502.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. DGA Optima Robert John was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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