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Spark Advanced – Combo Dual Arch Symetri

by Ormco Corporation EUDAMED

Active European Union

Ref 728-3030-DC-SModel 728-*

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0889989-Sprk_Clr_Align-48 Basic UDI-DIDate19 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Spark *
Model / Reference
728-*, 728-3030-DC-S
Primary DI / UDI-DI
00889989089486
Basic UDI-DI
0889989-Sprk_Clr_Align-48
Direct Marketing DI
00889989089486
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000038085
Authorised representative
KERR ITALIA SRL IT-AR-000007600

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

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