EU → US Device Access

Rontis Corporation SA

CH-MF-000031411 · Switzerland · Zug

Rontis Corporation SA is registered in the European database on medical devices as a manufacturer, with 443 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I440
Class IIa3

Most frequent device types declared: Europa Ultra™ Family, InRo® Family, EL20/20, IO10/20, IN27/25.

Among these devices, 443 are declared sterile.

Authorised representative in the Union: GR-AR-000023077.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED443
Country of registrationSwitzerland
⚠️ 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.

Notified body certificates

CertificateStatusExpiry
44912221174issued2029-03-14
44911221174issued2029-03-14

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