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ITE Transducer Array Small white

by Novocure GmbH Switzerland EUDAMED

Ref ITE4013WEUModel ITE1013B, ITE1013W, ITE1020B, ITE1020W

EMDN Z12040285

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number729010798ITEPAXJV Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
ITE Transducer Arrays
Model / Reference
ITE1013B, ITE1013W, ITE1020B, ITE1020W, ITE4013WEU
Primary DI / UDI-DI
07290107987578
Basic UDI-DI
729010798ITEPAXJV
EMDN Code
Z12040285 General medicine therapeutic treatment instruments - consumables
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CH-MF-000029002
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Novocure GmbH

See all devices from Novocure GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 07290107987578|729010798ITEPAXJV 61 fields · synced 24 Oct 2026