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Hamerz Medical / EDGE

by Hamerz Medical CO. EUDAMED

Active European Union

Ref IFUFILE23V02Model EDGE File

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number62603196EDGE-FILEQF Basic UDI-DIDate19 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Rotary File
Model / Reference
EDGE File, IFUFILE23V02
Primary DI / UDI-DI
06260319648537
Basic UDI-DI
62603196EDGE-FILEQF
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
IR-MF-000052221
Authorised representative
Source of Commerce GmbH DE-AR-000050360

Other devices from Hamerz Medical CO.

  • Edge

    Class IIa

Properties

Show properties
Other properties (13)
  • Sterile: No
  • 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