EU → US Device Access

SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság

HU-MF-000006381 · Hungary · Debrecen

SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság is registered in the European database on medical devices as a manufacturer, with 7 624 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7 624

Among these devices, 7 624 are declared reusable.

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 EUDAMED7 624
Country of registrationHungary
⚠️ 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
25 0316 QA/NBissued2030-08-14

Other manufacturers in Hungary

All Hungary manufacturers →