Skip to content

EcoFit® 2M

by implantcast GmbH 61 variants

Ref 29062854Model ECO2MHEADPE

Active European Union

CE MDR

Valid until

9 Jul 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4048844ECO2MHEADPEZ6 Basic UDI-DI 04048844240295UDI-DIDate18 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13211GB450250710 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    10 Jul 2025
    Expires
    9 Jul 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
ECO2MHEADPE, 29062854
Primary DI / UDI-DI
04048844240295
Basic UDI-DI
4048844ECO2MHEADPEZ6
EMDN Code
P0908030502 Double-mobility acetabular components inserts
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
DE-MF-000010002

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

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