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Insert PE HELMED II à débord pour intérieur

by Evolutis France EUDAMED

Ref H29 OT28020 (AXI)Model Cementless cups

EMDN P090803040103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03701271035605 Basic UDI-DIDate8 Oct 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
Helmed Ii
Model / Reference
Cementless cups, H29 OT28020 (AXI)
Primary DI / UDI-DI
03701271035605
Basic UDI-DI
B-03701271035605
EMDN Code
P090803040103 Retentive polyethylene hip prostheses inserts, anti-dislocation
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000492

Other devices from Evolutis

See all devices from Evolutis →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 03701271035605|B-03701271035605 61 fields · synced 24 Oct 2026