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 IIa | 316 |
|---|---|
| Class IIb | 256 |
| Class I | 21 |
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 register | Registered with FDA |
|---|---|
| Matched entry | LASAK S.R.O. (CZ) · FDA 3010869261 |
| Devices in EUDAMED | 593 |
| Country of registration | Czechia |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023-MDR/TD-038/A | supplemented | 2028-10-27 |
2023-MDR/TD-037 | issued | 2028-10-27 |
2023-MDR/QS-041 | issued | 2028-10-27 |
2023-MDR/QS-040 | issued | 2028-10-27 |
2023-MDR/QS-039/A | supplemented | 2028-10-27 |
2023-MDR/QS-038/A | supplemented | 2028-10-27 |
2023-MDR/QS-037 | issued | 2028-10-27 |