EU → US Device Access

L I N E T spol. s r.o.

CZ-MF-000009320 · Czechia · Slaný

L I N E T spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 650 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa650

Among these devices, 47 are declared 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 registerRegistered with FDA
Matched entryLINET spol. s r.o. (CZ) · FDA 3008058231
Devices in EUDAMED650
Country of registrationCzechia

Notified body certificates

CertificateStatusExpiry
HZ 1031322-1supplemented2029-09-15

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