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Cotyle HELMED II press-fit / int. Conique

by Evolutis EUDAMED

Active European Union

Ref H29 OT062 (AXI)Model Cementless cups

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03701271035643 Basic UDI-DIDate1 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

FranceFranceFranceFranceFrance
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

EU market availability

Available in 1 country, as listed in EUDAMED:

  • France

Last checked 27 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Helmed Ii
Model / Reference
Cementless cups, H29 OT062 (AXI)
Primary DI / UDI-DI
03701271035643
Basic UDI-DI
B-03701271035643
EMDN Code
P090803010201 Primary implant uncemented metal acetabular cups
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

  • 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