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by O&S Dental, Inc. United States EUDAMED

Ref 321-001

EMDN Q010404

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081744102TF0155 Basic UDI-DIDate17 Jan 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
321-001
Primary DI / UDI-DI
00810129520002
Basic UDI-DI
081744102TF0155
EMDN Code
Q010404 Orthodontic elastics, chains and springs
Device Class
Class I
Market of Registration
Belgium

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 4d827b2d-9c7d-4692-bc3c-322a56d21197 61 fields · synced 22 Oct 2026