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Monoflow

by Medex France EUDAMED

Ref FSDSU210, FSDSU111

EMDN A030499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-13700550400407 Basic UDI-DIDate17 Oct 2025RegisteredStatusActive
European UnionCE/MDD NumberB-13700550400407 Basic UDI-DIDate17 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Monoflow
Monoflow S Vial
Device Name
MonoFlow D CM ScanBag / NaCl Vial
ManyFlow/ Monoflow
Model / Reference
FSDSU210, FSDSU111
Primary DI / UDI-DI
13700550400407, 13700550400995
Basic UDI-DI
B-13700550400407, 37005504M0002YV
EMDN Code
A030499 Administration kits - other
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000414

Other devices from Medex

See all devices from Medex →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Animal Tissues
  • Administering Medicine
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 0cfc7410-a010-4cbe-bdf5-4da738a3ce6c 61 fields · synced 22 Oct 2026
  • EUDAMED 13700550400995|37005504M0002YV 61 fields · synced 18 May 2026