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Foley Balloon Catheter

by Poly Medicure Limited India EUDAMED

Ref 30194Model Foley Balloon Catheter

EMDN U020202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890209530303E9 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Foley Balloon Catheter, 30194
Primary DI / UDI-DI
08902095301944
Basic UDI-DI
890209530303E9
EMDN Code
U020202 Ureteral catheters with flute tip with balloon
Device Class
Class IIa
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 & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 05f4cc7d-c460-4549-9671-0e438cb4713e 61 fields · synced 24 Oct 2026