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Spark 35 R2 - Dual Arch

by Ormco Corporation

Ref 728-3236-DModel 728-*

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0889989-Sprk_Clr_Align-48 Basic UDI-DI 00889989089110UDI-DIDate19 Sep 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Spark *
Model / Reference
728-*, 728-3236-D
Primary DI / UDI-DI
00889989089110
Basic UDI-DI
0889989-Sprk_Clr_Align-48
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
EU 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