EU → US Device Access

Hermes Medical Solutions AB

SE-MF-000023032 · Sweden · Stockholm

Hermes Medical Solutions AB is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5
Class IIb2

Most frequent device types declared: Version 3.0.

Among these devices, 4 are declared active.

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 registerRegistered with FDA
Matched entryHERMES MEDICAL SOLUTIONS, AB (SE) · FDA 9710645
Devices in EUDAMED7
Country of registrationSweden

Notified body certificates

CertificateStatusExpiry
28620167501-01amended2028-10-03

Other manufacturers in Sweden

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