EU → US 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 I7
Class IIa6
Class IIb1

Most frequent device types declared: 10ml tube (box by 25 tubes), VOLSOFT, 1 ml syringe (box by 3 syringes) , VBODY, 10 ml syringe (box by 1 syringe), VOLSTRONG, 1 ml syringe (box by 3 syringes), VOLMEDIUM,1 ml syringe (box by 2 syringes).

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

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 EUDAMED14
Country of registrationItaly
⚠️ 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.

Other manufacturers in Italy

All Italy manufacturers →