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Scala

by K-jump Health Co., Ltd. Taiwan EUDAMED

Ref KI-8360

EMDN V0301010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04252010683605 Basic UDI-DIDate2 Oct 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
infrared thermometer
Model / Reference
KI-8360
Primary DI / UDI-DI
04252010683605
Basic UDI-DI
B-04252010683605
EMDN Code
V0301010202 Non-contact digital thermometers
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000020665
Authorised representative
Polygreen Germany GmbH DE-AR-000019484

Other devices from K-jump Health Co., Ltd.

See all devices from K-jump Health Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 04252010683605|B-04252010683605 61 fields · synced 24 Oct 2026