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by Episurf Operations AB EUDAMED

Active European Union

Ref 53420

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+EPIS534200 Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
53420
Primary DI / UDI-DI
+EPIS534200
Basic UDI-DI
B-+EPIS534200
EMDN Code
P091399 Orthopaedic implant instruments, single-use - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SE-MF-000025702

Related devices

Category: Joint prosthesis implantation kit, single-use

Other devices from Episurf Operations Ab

See all devices from Episurf Operations Ab →

Properties

Show properties
  • 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