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Orthodontic Wires

by Hangzhou Westlake Biomaterial Co., Ltd. EUDAMED

Active European Union

Model Stainless steel Archwire(Standard) Rectangular Wire 0.020×0.020 Inch Upper

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06951860613357 Basic UDI-DIDate13 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  • Withdrawn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 Wires
Model / Reference
Stainless steel Archwire(Standard) Rectangular Wire 0.020×0.020 Inch Upper
Primary DI / UDI-DI
06951860613357
Basic UDI-DI
B-06951860613357
EMDN Code
Q010405 Orthodontic wires
Device Class
Class IIa
Market of Registration
France

Manufacturer details

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

Other devices from Hangzhou Westlake Biomaterial Co., Ltd.

See all devices from Hangzhou Westlake Biomaterial Co., Ltd. →

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