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Poli̇fleks

by Polifarma İlaç San. ve Tic. A.Ş. Türkiye EUDAMED

Ref 15001018Model PVC BAG 2000 ML

EMDN A03040299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699606684954 Basic UDI-DIDate28 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
1.5% Glycine Urological Irrigation Solution
Model / Reference
PVC BAG 2000 ML, 15001018
Primary DI / UDI-DI
08699606684954
Basic UDI-DI
B-08699606684954
EMDN Code
A03040299 Irrigation kits, single-use - other
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000023645

Other devices from Polifarma İlaç San. ve Tic. A.Ş.

See all devices from Polifarma İlaç San. ve Tic. A.Ş. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8ad7ca37-af91-456b-a621-ea625ae48b1d 61 fields · synced 23 Oct 2026