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Biomarker Analysis Platform

by Nightingale Health Oyj Finland EUDAMED

Ref NGH-0102

EMDN W0201010192,W0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-NGH-01026Z Basic UDI-DIDate27 Jul 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
NGH-0102
Primary DI / UDI-DI
D-NGH-01026Z
Basic UDI-DI
B-NGH-01026Z
EMDN Code
W0201010192,W0299
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000021253

Other devices from Nightingale Health Oyj

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED d086649a-ce98-477f-8382-f2f10ca80d39 61 fields · synced 22 Oct 2026