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Dormo-Spec

by Telic, S.A.U. Spain EUDAMED

Ref 4080

EMDN Z12021085

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8427734OTOSCOPESPECULUMFB Basic UDI-DIDate31 Jul 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
Disposable speculum for otoscope
Model / Reference
4080
Primary DI / UDI-DI
08427734007587
Basic UDI-DI
8427734OTOSCOPESPECULUMFB
EMDN Code
Z12021085 ENT endoscopy instruments - consumables
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001853

Other devices from Telic, S.A.U.

See all devices from Telic, S.A.U. →

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 4fd8c4b6-23c9-4ea7-a61b-074e34bf4782 61 fields · synced 22 Oct 2026