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Bdem-01

by Neko Health AB Sweden EUDAMED

Ref K9302000AModel NekoLens

EMDN Z12040118

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735017092_BDEM_DQ Basic UDI-DIDate19 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Bdem-01
Model / Reference
K9302000A, NekoLens
Primary DI / UDI-DI
07350170920015, 07350170920244
Basic UDI-DI
735017092_BDEM_DQ, 735017092NELHT
EMDN Code
Z12040118 Video dermatoscopes
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000045605

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 c39ff3c7-e1a5-4eae-ab9e-4a89abeeee3b 61 fields · synced 22 Oct 2026
  • EUDAMED 07350170920244|735017092NELHT 61 fields · synced 15 Jul 2026