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Salient

by Eon Meditech Pvt. Ltd India EUDAMED

Ref PE5150SModel Rhinology

EMDN Q0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904428710126 Basic UDI-DIDate19 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 24 Oct 2026

Device Name
External Thermoplastic Splint Small
Model / Reference
Rhinology, PE5150S
Primary DI / UDI-DI
08904428710126
Basic UDI-DI
B-08904428710126
EMDN Code
Q0399 ENT devices - other
Device Class
Class I
Market of Registration
Spain

Manufacturer details

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

Other devices from Eon Meditech Pvt. Ltd

See all devices from Eon Meditech Pvt. Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • 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 9852cc84-04ba-4b49-b839-60bc3e824bac 61 fields · synced 24 Oct 2026