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Bone Profiler

by LASAK s.r.o. EUDAMED

Active European Union

Ref 2561.00Model Cover Screw Mill; Bone Profiler

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number85955730045Y6 Basic UDI-DIDate5 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023-MDR/QS-039/A Supplemented

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    3 Jul 2026
    Expires
    27 Oct 2028
    Reason
    Other

Specification

EUDAMED

Device Name
BioniQ Instruments
Model / Reference
Cover Screw Mill, Bone Profiler, 2561.00
Primary DI / UDI-DI
08595573023393
Basic UDI-DI
85955730045Y6
EMDN Code
L159099 Odontostomatology instruments, reusable - other
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000031907

Other devices from LASAK s.r.o.

See all devices from LASAK s.r.o. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No