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Infusion set

by Sunrise Medical Co., Ltd. EUDAMED

Active European Union

Ref IS2-V6F24 G 180 4h00-F-4003Model IV01 CV DF/180A, IV01,IV01W,IV01W/A,IV01W/RF,IV01W/Y,IV01W/NF,IV01W/FR,IV01W/VF,IV01/3W,IV01W/MF

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697565568DIS003QU Basic UDI-DIDate22 Apr 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  • Withdrawn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

Trade Name
Infusion set
Flowset-2 Iv Solution Administration Set with Flow Controller
Device Name
Disposable Infusion Sets
Model / Reference
IV01 CV DF/180A, IS2-V6F24 G 180 4h00-F-4003, IV01, IV01W, IV01W/A, IV01W/RF, IV01W/Y, IV01W/NF, IV01W/FR, IV01W/VF, IV01/3W, IV01W/MF
Primary DI / UDI-DI
06975655680645
Basic UDI-DI
697565568DIS003QU, 697565568IV01WSF
EMDN Code
A03010101 Infusion controllers with or w/o air inlet
Device Class
Class I
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000029852
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Sunrise Medical Co., Ltd.

See all devices from Sunrise Medical Co., Ltd. →

Properties

Show properties
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No