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KEWS300

by Syncrophi Systems Ltd Ireland EUDAMED

Ref SSL_KEWS_002Model KEWS300

EMDN Z12030201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-53915461200062 Basic UDI-DIDate11 Mar 2025RegisteredStatusActive

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
KEWS300, SSL_KEWS_002
Primary DI / UDI-DI
53915461200062
Basic UDI-DI
B-53915461200062
EMDN Code
Z12030201 Central information computing systems
Device Class
Class IIb
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000038815

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 ee040ae2-bcac-4fa7-aa14-dbb5f1c5c9f6 61 fields · synced 22 Oct 2026