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NIO Imaging System

by Invenio Imaging Inc. United States EUDAMED

Ref PRT 03-2082 EMDN W0202050302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08603960019001LV Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
PRT 03-2082
Primary DI / UDI-DI
00860396001933
Basic UDI-DI
08603960019001LV
Direct Marketing DI
00860396001933
EMDN Code
W0202050302 Laser scanning microscopes
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000047250
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Invenio Imaging, Inc.

Properties & raw data

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

Sources (1)

  • EUDAMED 00860396001933|08603960019001LV 61 fields · synced 25 Oct 2026