EU → US Device Access

SOFT MEDICAL AESTHETICS

FR-MF-000009361 · France · PARIS

SOFT MEDICAL AESTHETICS is registered in the European database on medical devices as a manufacturer, with 51 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa51

Most frequent device types declared: CP2090/XL, NP2540XL, NP3006XL, CS3025/L, CP2530/XL.

Among these devices, 51 are declared sterile.

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 EUDAMED51
Country of registrationFrance
⚠️ 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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