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Infusion set IS PREMIUM

by Margomed Spółka Akcyjna EUDAMED

Active European Union

Ref 001 905PModel Infusion set type: IS; with injection site; PREMIUM; PRO; AIR PASS; SAFETY; with needle-free injection site; back check valve; PVC FREE; UV protected infusion set

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590455399301179 Basic UDI-DIDate10 Sep 2025RegisteredStatusActive

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  • Withdrawn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
Infusion Set
Model / Reference
Infusion set type: IS, with injection site, PREMIUM, PRO, AIR PASS, SAFETY, with needle-free injection site, back check valve, PVC FREE, UV protected infusion set, 001 905P
Primary DI / UDI-DI
05904553993480
Basic UDI-DI
590455399301179
EMDN Code
A03040199 Infusion kits (with or w/o pump), single-use - other
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000009261

From the manufacturer

Manufacturer's product page: Przyrząd do przetaczania płynów infuzyjnych IS PRO AIR PASS

Other devices from Margomed Spółka Akcyjna

See all devices from Margomed Spółka Akcyjna →

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