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Stainless Steel Archwires

by Astar Orthodontics Inc. 25 variants

Ref 6171-2027-NTModel Niti SuperElastics, Niti Heat Activated, Niti Reverse, Niti Open/Close spring, Copper Niti, TMA,Stainless Steel

Active European Union

CE MDR

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69416735WRS735YN Basic UDI-DI 06941673553100UDI-DIDate15 May 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device name
Orthodontic Archwires
Model / reference
Niti SuperElastics, Niti Heat Activated, Niti Reverse, Niti Open/Close spring, Copper Niti, TMA, Stainless Steel, 6171-2027-NT
Primary DI / UDI-DI
06941673553100
Basic UDI-DI
69416735WRS735YN
Direct marketing DI
06941673553100
EMDN code
Q010405 Orthodontic wires
Device class
Class IIa
EU registration type
Standard device
EU 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

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No