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Episealer Condyle Solo

by Episurf Operations AB United States EUDAMED

Ref 11117

EMDN P090999

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+EPIS111170 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
11117
Primary DI / UDI-DI
+EPIS111170
Basic UDI-DI
B-+EPIS111170
EMDN Code
P090999 Knee prostheses - other
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
SE-MF-000025702

Other devices from Episurf Operations Ab

See all devices from Episurf Operations Ab →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 8be8b5c4-ecaf-4b1c-9cc8-f99d2dac2401 61 fields · synced 22 Oct 2026