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Nivolis

by Vivardis France EUDAMED

Ref NivolisAnton, NivolisMonitor

EMDN Z1203020480

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3770027367024XV Basic UDI-DIDate25 Aug 2022RegisteredStatusActive

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
NivolisAnton
NivolisMonitor
Model / Reference
NivolisAnton, NivolisMonitor
Primary DI / UDI-DI
03770027367024, 03770027367000
Basic UDI-DI
3770027367024XV, 3770027367000XF
Direct Marketing DI
03770027367024
EMDN Code
Z1203020480, Z1203019003
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000015885

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 5150720a-fe15-40c1-b349-72f0a9493afc 61 fields · synced 22 Oct 2026
  • EUDAMED 03770027367000|3770027367000XF 61 fields · synced 18 May 2026