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Surgical dental devices

by Euroteknika 191 variants

Ref AFI_22.120

Active European Union

CE MDR

Valid until

1 Aug 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Overview

Our Surgical Dental Devices are designed for precision and effectiveness in dental procedures. Our devices meet the highest standards of quality, safety, and efficacy, making them an ideal choice for medical professionals and patients alike.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0425-MDR-030089-03 Date14 Sep 2026IssuedStatusActive expires 1 Aug 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030089-03 Active

    Quality management system EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
AFI_22.120
Primary DI / UDI-DI
03700977510218
Basic UDI-DI
37009775foretE5
EMDN Code
Q010399 Surgical dental devices - other
Device Class
Class IIa
EU 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

  • iBone G

    Class IIb

  • Empty surgical kit

    Class I

  • Origin

    Class IIb

See all devices from Euroteknika →

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