EU → North America 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: EE609, EE669/WW, EE717.

Authorised representative in the Union: Miromed Srl.

Devices declared under this manufacturer

Catalogue references include EE609, EE641/WW, EE663/WW, EE669/WW, EE717.

European nomenclature codes declared: Q0199, Q019008.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationSwitzerland

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

Device-level evidence

Devices with a numeric GTIN5
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. Miromed Group SA was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030199-00issued2031-06-22

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