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Iconic Dual 2mm x 5”Square Midnight Blue

by DB Orthodontics Limited EUDAMED

Active European Union

Ref DBL3-0662Model Thermoforming

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50560910ThermoformingCK Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Thermoforming
Model / Reference
Thermoforming, DBL3-0662
Primary DI / UDI-DI
05056091030070
Basic UDI-DI
50560910ThermoformingCK
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
GB-MF-000023271
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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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