EU → North America Device Access

Dermoaroma Italy srl

IT-MF-000034895 · Italy · Roma

Dermoaroma Italy srl is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6
Class I7
Class IIb1

Most frequent device types declared: 1 ml syringe (box by 2 syringes), 10ml tube (box by 25 tubes), 10ml tube (box by 6 tubes), 15ml tube (box by 6 tubes), Medical device for preparation of autologous platelet-rich plasma (P.R.

Among these devices, 13 are declared sterile, 7 implantable.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include DPG1105, DPG1110D, DPG1505, DPG2510, VOLOMIS BODY, Volomis Medium.

European nomenclature codes declared: P900402, B0501, V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN14
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. Dermoaroma Italy srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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