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IV Screen

by Monidor Oy Finland EUDAMED

Ref V004456Model IV Screen

EMDN Z12030392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI24/00000050 Date8 Jan 2026IssuedStatusActive expires 14 Aug 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI24/00000050 Supplemented

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    8 Jan 2026
    Expires
    14 Aug 2027
    Valid from
    9 Jan 2026
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Device Name
IV Screen Infusion monitoring software
Model / Reference
IV Screen, V004456
Primary DI / UDI-DI
06430066950041
Basic UDI-DI
643006695V0046S
EMDN Code
Z12030392 Infusion instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000007941

Other devices from Monidor Oy

  • Monidor Vitals

    Class IIb

  • Monidrop W

    Class I

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED db16de36-a5c9-4b57-81f8-7d8584f5c4d5 61 fields · synced 22 Oct 2026