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Winged Infusion Set with/without safety features

by Poly Medicure Limited 11 variants

Ref 13510Model Safety Winged 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890209513511EH Basic UDI-DI 08902095135105UDI-DIDate13 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Winged Infusion Set with/without safety
Model / Reference
Safety Winged Infusion set, 13510
Primary DI / UDI-DI
08902095135105
Basic UDI-DI
890209513511EH
EMDN Code
A01010202 Butterfly needles, w/o safety systems
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000043009
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Poly Medicure Limited

See all devices from Poly Medicure Limited →

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