Skip to content

Spectrum-2

by Neko Health AB Sweden EUDAMED

Ref 100515

EMDN Z12040102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735017092_SPECTRUM2_TW Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Spectrum-2
Model / Reference
100515
Primary DI / UDI-DI
07350170920237
Basic UDI-DI
735017092_SPECTRUM2_TW
EMDN Code
Z12040102 Equipment for analysis of the physiological parameters of the skin
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000045605

Other devices from Neko Health AB

  • Neko Health Spectrum-2

    Class II

  • Echo-2

    Class II

  • Positioner-1

    Class I

  • Bdem-01

    Class I

  • Derma-2

    Class I

  • Spectrum-1

    Class I

See all devices from Neko Health AB →

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 ef72e29e-1176-47ec-8f55-f421554c485a 61 fields · synced 23 Oct 2026