Skip to content

Trephine for guided surgery – d3.35 (GS)

by LASAK s.r.o.

Ref 2521.00Model Trephine; Trephine for guided surgery

Active European Union

CE MDR

Valid until

27 Oct 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2023-MDR/QS-039/A Date3 Jul 2026IssuedStatusActive expires 27 Oct 2028

Certificates

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
BioniQ Instruments
Model / Reference
Trephine, Trephine for guided surgery, 2521.00
Primary DI / UDI-DI
08595573020606
Basic UDI-DI
85955730003XN
EMDN Code
L159099 Odontostomatology instruments, reusable - other
Device Class
Class IIa
EU 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