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TRU-COMFI (Lead)

by Cworld South Korea EUDAMED

Ref N-XR-1-35P-LModel N-XR-1 EMDN T030499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8800063400302VV Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Front Shield Apron
Model / Reference
N-XR-1, N-XR-1-35P-L
Primary DI / UDI-DI
08800063400906
Basic UDI-DI
8800063400302VV
EMDN Code
T030499 Radiotherapy protection devices - other
Device Class
Class I
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
KR-MF-000047459
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Cworld

See all devices from Cworld →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 5eb62eb2-1c4a-4ebc-ab2d-c0b10091a0ce 61 fields · synced 23 Oct 2026