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NiTi Orthodontic Wire

by Beijing Smart Technology Co., Ltd. 55 variants

Ref SM-R-1622-L

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69417841NTWIRE56 Basic UDI-DI 06941784100583UDI-DIDate16 Jun 2022RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Trade Name
Nitinol (NiTi) Orthodontic Wires
Device Name
NiTi Orthodontic Wire
Model / Reference
SM-R-1622-L
Primary DI / UDI-DI
06941784100583
Basic UDI-DI
69417841NTWIRE56, B-06941784100583
EMDN Code
Q010405 Orthodontic wires
Device Class
Class IIa
EU market of registration
France
Italy

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