Skip to content

Salient

by Eon Meditech Pvt. Ltd India EUDAMED

Ref PE3115S Model Ear Ventilation Tube

EMDN P02010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904428716708 Basic UDI-DIDate17 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
T Tube(Silicone) (L: 6mm)
Model / Reference
Ear Ventilation Tube, PE3115S
Primary DI / UDI-DI
08904428716708
Basic UDI-DI
B-08904428716708
EMDN Code
P02010201 Transtympanic drainage prostheses (ventilation tubes)
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000014457
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c113a5dc-48b1-4680-9072-4e8ed627a180 61 fields · synced 22 Oct 2026