EU → US Device Access

Flídr medical s.r.o.

CZ-MF-000012476 · Czechia · Polička

Flídr medical s.r.o. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb24

Most frequent device types declared: SR, NR-U, NR-H, SM-P, SM-Z.

Among these devices, 24 are declared active.

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 EUDAMED24
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
23 0493 QR/NBsupplemented2028-10-31

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