EU → US Device Access

Arcomed AG

CH-MF-000035749 · Switzerland · Koten

Arcomed AG is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Among these devices, 9 are declared active.

Authorised representative in the Union: DE-AR-000016892.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
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
G15 013006 0024issued2031-07-08
G15 013006 0024amended2031-07-08

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