EU → US Device Access

MEDICA FILTER spol. s r.o.

CZ-MF-000018854 · Czechia · Kašperské Hory

MEDICA FILTER spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Most frequent device types declared: Rouška s krajovou adhezí a adhezním otvorem.

Among these devices, 9 are declared sterile.

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 EUDAMED10
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
2024-MDR/QS-046issued2029-07-16
2024-MDR/QS-045issued2029-07-16

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