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iBone G

by Euroteknika EUDAMED

Active European Union

Ref IGR3548120

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37009775implant-01A9 Basic UDI-DIDate25 Sep 2026RegisteredStatusActive

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  • Withdrawn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)
  • 0425-MDR-030089-03 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    14 Sep 2026
    Expires
    1 Aug 2029

Specification

EUDAMED

Device Name
Dental implant
Model / Reference
IGR3548120
Primary DI / UDI-DI
03700977511598
Basic UDI-DI
37009775implant-01A9
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000004032

Other devices from Euroteknika

  • iBone S

    Class IIb

  • Naturactis

    Class IIb

  • Naturall+

    Class IIb

  • Empty surgical kit

    Class I

  • Origin

    Class IIb

  • Analog

    Class I

See all devices from Euroteknika →

Properties

  • Sterile
  • Implantable
  • Sutures

Other properties (11)

  • Reusable: 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