EU → US Device Access

Medicop - specialna oprema d.o.o.

SI-MF-000002144 · Slovenia · Murska Sobota

Medicop - specialna oprema d.o.o. is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: Terminal unit, Gas Aspirator, FQ, AGSS , Bead Head Unit.

Among these devices, 3 are declared implantable, 27 active, 6 with a measuring function.

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 registerNot found in the FDA register
Devices in EUDAMED28
Country of registrationSlovenia
⚠️ 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
G10 038393 0019issued2029-04-21

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