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Dormo-Spec

by Telic, S.A.U. 12 variants

Ref 4090

Dormo-Spec (4090) is a Class I device made by Telic, S.A.U., registered in EUDAMED on 31 Jul 2024 (Basic UDI-DI 8427734OTOSCOPESPECULUMFB), active as of 23 Oct 2026.

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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8427734OTOSCOPESPECULUMFB Basic UDI-DI 08427734009963UDI-DIDate31 Jul 2024RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 8427734OTOSCOPESPECULUMFB — open Devices and search for it

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Disposable speculum for otoscope
Model / reference
4090
Primary DI / UDI-DI
08427734009963
Basic UDI-DI
8427734OTOSCOPESPECULUMFB
EMDN code
Z12021085 ENT endoscopy instruments - consumables
Device class
Class I
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001853

Similar devices in this category

Other devices filed under ENT ENDOSCOPY INSTRUMENTS.

Other devices from Telic, S.A.U.

See all devices from Telic, S.A.U. →

Properties

Other properties (14, all answered No)