EU → US Device Access

Miromed Group SA

CH-MF-000048373 · Switzerland · Chiasso

Miromed Group SA is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: EE669/WW, EE717, EE609.

Authorised representative in the Union: IT-AR-000029680.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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
0425-MDR-030199-00issued2031-06-22

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