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

Most frequent device types declared: BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Pl, C-guide for guided surgery; Drill guide for guided drill; Drill stop f, Cast-On abutment, BioniQ, Cover Screw Mill; Bone Profiler, Drill Extension; Explantation Wrench; Extended Driver; Extension Wrenc.

Among these devices, 99 are declared sterile, 277 implantable, 114 reusable, 1 with a measuring function.

Devices declared under this manufacturer

• BioniQ implant – straight
• BioniQ implant – tapered
• Cast-On abutment, BioniQ, indexed
• Cover Screw Mill
• Drill stop for drills S2.9, S3.5, S4.0, T4.0 for implants L14
• Guided fixation pin – vertical, QR/H8/d5.2 (GS)
• Hex Screwdriver for angulated channels
• PLS BioniQ – bridge support, CoCr
• Premill abutment, BioniQ, AG – Ti
• ProImplant – Insertion Tool
• Screw-On abutment – angled
• Temporary abutment – indexed

Showing 12 of 593 declared devices.

Catalogue references include 2125.03, 2150.04, 2154.00, 2161.20, 2219.07, 2344.3.

European nomenclature codes declared: P01020180, L159099, Q010207, P01020101, P900402, P900403.

United States market access

Device-level evidence

Canadian market access

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. LASAK s.r.o. is registered in the United States but was not found in the Canadian register.

Notified body certificates

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