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by O&S Dental, Inc. United States EUDAMED

Ref 323-023

EMDN Q010404

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081012952TF01ZM Basic UDI-DIDate29 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Elastomerics
Model / Reference
323-023
Primary DI / UDI-DI
00810129521153
Basic UDI-DI
081012952TF01ZM
EMDN Code
Q010404 Orthodontic elastics, chains and springs
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000023206
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Related devices

Category: Orthodontic retainer

Other devices from O&S Dental, Inc.

See all devices from O&S Dental, Inc. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 62c39592-463e-4fad-9b5b-46ea5c659e08 61 fields · synced 22 Oct 2026