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Paragon High Offset Ha Coated Stem SIZE8

by Covision Medical Technologies Ltd.

Ref 63.1138Model PARAGON HIGH OFFSET HA COATED STEM SIZE8

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05051659114643 Basic UDI-DI 05051659114643UDI-DIDate25 Mar 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
PARAGON HIGH OFFSET HA COATED STEM SIZE8, 63.1138
Primary DI / UDI-DI
05051659114643
Basic UDI-DI
B-05051659114643
EMDN Code
P090804010201 Uncemented femoral stems for primary implant, with fixed neck, straight
Device Class
Class III
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
GB-MF-000025081
Authorised representative
Covision Medical Technologies (Ireland) Limited IE-AR-000031129

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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