EU → US Device Access

LASAK s.r.o.

CZ-MF-000031907 · Czechia · Hloubětín, Praha 9

LASAK s.r.o. is registered in the European database on medical devices as a manufacturer, with 593 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa316
Class IIb256
Class I21

Most frequent device types declared: Uni-Base, BioniQ; Uni-Base AN, BioniQ, Screw-On abutment, Esthetic abutment, STANDARD abutment, Gingiva former, PORESORB-TCP, Cover Screw Mill; Bone Profiler.

Among these devices, 99 are declared sterile, 277 implantable, 114 reusable, 1 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 entryLASAK S.R.O. (CZ) · FDA 3010869261
Devices in EUDAMED593
Country of registrationCzechia

Notified body certificates

CertificateStatusExpiry
2023-MDR/TD-038/Asupplemented2028-10-27
2023-MDR/TD-037issued2028-10-27
2023-MDR/QS-041issued2028-10-27
2023-MDR/QS-040issued2028-10-27
2023-MDR/QS-039/Asupplemented2028-10-27
2023-MDR/QS-038/Asupplemented2028-10-27
2023-MDR/QS-037issued2028-10-27

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