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Orthodontic Lingual Buttons

by Astar Orthodontics Inc. United States EUDAMED

Ref 4340-06

EMDN Q010403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69416735BTN735PQ Basic UDI-DIDate13 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Orthodontic Lingual Buttons
Model / Reference
4340-06
Primary DI / UDI-DI
06941673552042
Basic UDI-DI
69416735BTN735PQ
Direct Marketing DI
06941673552042
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000028647
Authorised representative
BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480

Other devices from Astar Orthodontics Inc.

See all devices from Astar Orthodontics Inc. →

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 (1)

  • EUDAMED 06941673552042|69416735BTN735PQ 61 fields · synced 25 Oct 2026