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Unic®

by Evolutis France EUDAMED

Ref E27 021Model UNIC® Reverse Shoulder

EMDN P0901040201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376025538P090103RTICTZ Basic UDI-DIDate22 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 017-00-00-MDR Issued

    Technical documentation EU MDR

    Notified body
    ITALCERT SRL 0426
    Issued
    6 Apr 2023
    Expires
    5 Apr 2028

Specification

EUDAMED · synced 22 Oct 2026

Device Name
UNIC® Reverse Shoulder
Model / Reference
UNIC® Reverse Shoulder, E27 021
Primary DI / UDI-DI
03760255384634
Basic UDI-DI
376025538P090103RTICTZ
EMDN Code
P0901040201 Shoulder prostheses non modular stems
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000492

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED f0146d33-28e6-43c6-b7c8-9e57c310d6f9 61 fields · synced 22 Oct 2026