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IRENE Ceramic Femoral Head

by Tianjin Zhengtian Medical Instrument Co., Ltd. 11 variants

Ref Ce32412801

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06921814266137 Basic UDI-DI 06921814266137UDI-DIDate18 Sep 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
IRENE Ceramic Femoral Head
Model / Reference
Ce32412801
Primary DI / UDI-DI
06921814266137
Basic UDI-DI
B-06921814266137
EMDN Code
P090804050201 Ceramic femoral heads, total hip replacement
Device Class
Class III
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000020115
Authorised representative
Inion Oy FI-AR-000046224

Other devices from Tianjin Zhengtian Medical Instrument Co., Ltd.

See all devices from Tianjin Zhengtian Medical Instrument Co., Ltd. →

Properties

  • 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