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Spectrum-1

by Neko Health AB Sweden EUDAMED510(k)

Ref 101718510(k) K254129

Product code MUDEMDN Z12040102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK254129 Date22 May 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number735017092_SPECTRUM_XP Basic UDI-DIDate19 Jan 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Device Name
Spectrum-1
Model / Reference
101718
Primary DI / UDI-DI
07350170920145
Basic UDI-DI
735017092_SPECTRUM_XP
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

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 (2)

  • EUDAMED 2e48a16f-2c8b-4b64-a1b2-e45def209d4b 85 fields · synced 22 Oct 2026
  • FDA 510(k) K254129 1 fields · synced 5 Jun 2026