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Orthodontic Brackets

by Hangzhou Westlake Biomaterial Co., Ltd. EUDAMED

Active European Union

Model Active Self Ligating Bracket ROTH 0.022"(Hook on 3)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06951860605888 Basic UDI-DIDate11 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Orthodontic Brackets
Model / Reference
Active Self Ligating Bracket ROTH 0.022"(Hook on 3)
Primary DI / UDI-DI
06951860605888
Basic UDI-DI
B-06951860605888
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000039344
Authorised representative
Lotus NL B.V. NL-AR-000000121

Related devices

Category: Orthodontic tube

Other devices from Hangzhou Westlake Biomaterial Co., Ltd.

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Properties

Show properties
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No