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Extracorporeal Shock Wave Lithotripter (ESWL)

by İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi Türkiye EUDAMED

Ref IMES-900Model Spark EMDN Z12160101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680050920323 Basic UDI-DIDate31 Jul 2025RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
Spark, IMES-900
Primary DI / UDI-DI
08680050920323
Basic UDI-DI
B-08680050920323
EMDN Code
Z12160101 Extracorporeal lithotripters
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000024864

Other devices from İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi

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Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • 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 e4d33bd3-73d6-4d85-9a4f-71d8aae23218 61 fields · synced 22 Oct 2026