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Orleon

by Eon Meditech Pvt. Ltd India EUDAMED

Ref F2134Model Middle Ear Implant EMDN P02010101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904428700370 Basic UDI-DIDate21 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Fluoroplastic Total Prosthesis
Model / Reference
Middle Ear Implant, F2134
Primary DI / UDI-DI
08904428700370
Basic UDI-DI
B-08904428700370
EMDN Code
P02010101 Ossicular prostheses (porp and torp)
Device Class
Class IIb
Market of Registration
France

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
  • 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 fcbbe532-7334-44b3-ba2f-a5485a717d39 61 fields · synced 24 Oct 2026