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by Episurf Operations AB United States EUDAMED

Ref 53425

EMDN P091399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+EPIS534250 Basic UDI-DIDate4 May 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 23 Oct 2026

Model / Reference
53425
Primary DI / UDI-DI
+EPIS534250
Basic UDI-DI
B-+EPIS534250
EMDN Code
P091399 Orthopaedic implant instruments, single-use - other
Device Class
Class IIa
Market of Registration
Germany

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
Other properties (10)
  • Implantable: No
  • 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 +EPIS534250|B-+EPIS534250 61 fields · synced 23 Oct 2026