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NemoStudio

by Software Nemotec S.L. EUDAMED

Active European Union

Ref 25.0.0.3Model 25.0.0.5

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437023642NemotecSB Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
NemoStudio and its modules: NemoCast, NemoCeph, NemoCAD, NemoFAB, NemoFAB Ortho, NemoScan and NemoSmile
Model / Reference
25.0.0.5, 25.0.0.3
Primary DI / UDI-DI
08437023642085
Basic UDI-DI
8437023642NemotecSB
Direct Marketing DI
08437023642085
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000018790

Other devices from Software Nemotec Sl

See all devices from Software Nemotec Sl →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No