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Lingual Sheath

by Astar Orthodontics Inc.

Ref 4140-00

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69416735LS735QG Basic UDI-DI 06941673553148UDI-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  • Withdrawn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 Lingual Sheaths
Model / Reference
4140-00
Primary DI / UDI-DI
06941673553148
Basic UDI-DI
69416735LS735QG
Direct Marketing DI
06941673553148
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
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 (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