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UV protected infusion set IS PRO AIR PASS

by Margomed Spółka Akcyjna 3 variants

Ref 001 475Model 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

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590455399301179 Basic UDI-DI 05905386929981UDI-DIDate10 Sep 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

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, 001 475
Primary DI / UDI-DI
05905386929981
Basic UDI-DI
590455399301179
EMDN Code
A03040199 Infusion kits (with or w/o pump), single-use - other
Device Class
Class IIa
EU 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 do leków światłoczułych

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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