Skip to content

Nitinol (NiTi) Orthodontic Wires

by Beijing Smart Technology Co., Ltd. 116 variants

Ref SE-RC-R-1425-U

Active European Union

CE MDD

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 24 Oct 2026. What this means

Overview

Nitinol (NiTi) Orthodontic Wires are a type of medical device used in orthodontic treatment. These wires are made from nickel-titanium alloy and have been shown to be effective in straightening teeth. They are available for both fixed and removable appliances. For more information, consult a healthcare professional.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06941784100910 Basic UDI-DI 06941784100910UDI-DIDate26 Apr 2024RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
SE-RC-R-1425-U
Primary DI / UDI-DI
06941784100910
Basic UDI-DI
B-06941784100910, 69417841NTWIRE56
EMDN Code
Q010405 Orthodontic wires
Device Class
Class IIa
EU market of registration
Italy
France

Manufacturer details

EUDAMED SRN
CN-MF-000015988
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Beijing Smart Technology Co., Ltd

See all devices from Beijing Smart Technology Co., Ltd →

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