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Go-Taper Retraitement Sterile Kit

by Conception Et Fabrication De Produits Medicaux Et Paramedicaux

Ref 3166598Model Sterile Niti Engine Files

Active European Union

CE MDR

Valid until

29 Jun 2030

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0425-MDR-030134-01 Date15 Jun 2026IssuedStatusActive expires 29 Jun 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030134-01 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    15 Jun 2026
    Expires
    29 Jun 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Go-Taper Universal
Model / Reference
Sterile Niti Engine Files, 3166598
Primary DI / UDI-DI
03665318026318
Basic UDI-DI
3665318FILE001NY
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000010345

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • 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