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ITE Transducer Array Large Black

by Novocure GmbH

Ref ITE4020BEUModel ITE1013B, ITE1013W, ITE1020B, ITE1020W

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number729010798ITEPAXJV Basic UDI-DI 07290107987585UDI-DIDate24 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ITE Transducer Arrays
Model / Reference
ITE1013B, ITE1013W, ITE1020B, ITE1020W, ITE4020BEU
Primary DI / UDI-DI
07290107987585
Basic UDI-DI
729010798ITEPAXJV
EMDN Code
Z12040285 General medicine therapeutic treatment instruments - consumables
Device Class
Class IIb
EU 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

  • 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