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BiPolar Head D.46mm

by Intrauma S.p.A.

Ref IH05.1122.000.00Model hip.bh

Active European Union

CE MDD

Valid until

No date given

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08056693026591 Basic UDI-DI 08056693026591UDI-DIDate3 Nov 2026RegisteredStatusActive

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  • Withdrawn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
Filadelfia - Bipolar Head
Model / reference
hip.bh, IH05.1122.000.00
Primary DI / UDI-DI
08056693026591
Basic UDI-DI
B-08056693026591
EMDN code
P0908040503 Hip prostheses, bi-articular cups
Device class
Class III
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000005991

Other devices from Intrauma S.p.A.

See all devices from Intrauma S.p.A. →

Properties

  • Supplied sterile
  • Implantable

Other properties (12)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No