Skip to content

On-X Prosthetic Heart Valve

by On-X Life Technologies, Inc. United States EUDAMED

Ref ONXM-23 EMDN P0703020302

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00851788001266 Basic UDI-DIDate27 May 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  • Withdrawn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 25 Oct 2026

Model / Reference
ONXM-23
Primary DI / UDI-DI
00851788001266
Basic UDI-DI
B-00851788001266
EMDN Code
P0703020302 Bileaflet mechanical mitral valves
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000026354
Authorised representative
JOTEC GmbH DE-AR-000006801

Other devices from On-X Life Technologies, Inc.

See all devices from On-X Life Technologies, Inc. →

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 b5e5fa23-1166-496d-a0fa-b6097605ec81 61 fields · synced 25 Oct 2026