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KroniKare

by KroniKare Pte Ltd EUDAMED

Active European Union

Ref iTSCAN1, KKSCAN2

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060890010ITS3W Basic UDI-DIDate29 Nov 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
KroniKare iThermo Thermal Scanner
KroniKare Wound Scanner
Model / Reference
iTSCAN1, KKSCAN2
Primary DI / UDI-DI
05060890010034, 05060890010089
Basic UDI-DI
5060890010ITS3W, 506089001KKSCAN2DQ
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Market of Registration
Netherlands
Italy

Manufacturer details

EUDAMED SRN
SG-MF-000012230
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from KroniKare Pte Ltd

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No