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Edge

by Hamerz Medical CO. Iran EUDAMED

Ref IFUCOM23V01Model EDGE FLOW, EDGE COM EMDN Q01010103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number62600017EDGE-FLOWEG 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Universal Composite
Model / Reference
EDGE FLOW, IFUCOM23V01, EDGE COM
Primary DI / UDI-DI
06260001798472, 06260001798465
Basic UDI-DI
62600017EDGE-FLOWEG, 62600017EDGE-COM4U
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

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

Other devices from Hamerz Medical CO.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 01967727-1a2b-4fff-8d21-8c2f3e569376 61 fields · synced 24 Oct 2026
  • EUDAMED 06260001798465|62600017EDGE-COM4U 61 fields · synced 17 May 2026