EU → US Device Access

BEZNOSKA, s.r.o.

CZ-MF-000000543 · Czechia · Kladno

BEZNOSKA, s.r.o. is registered in the European database on medical devices as a manufacturer, with 3 481 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 992
Class I1 335
Class IIb154

Most frequent device types declared: ELIS, Type: T.

Among these devices, 1 463 are declared sterile, 1 489 implantable, 1 992 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 EUDAMED3 481
Country of registrationCzechia
⚠️ 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
2026-MDR/TD-018issued2031-03-05
2026-MDR/QS-018issued2031-03-05
2023-MDR/TD-005/Asupplemented2028-05-12
2023-MDR/QS-005/Asupplemented2028-05-12

Other manufacturers in Czechia

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