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Urolube

by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi Türkiye EUDAMED

Ref UL-L 006Model UROLUBE - Sterile Lubricant Gel With Lidocaine (CHG Free), 6mL, 25pcs/box

EMDN U040199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-18698703333984 Basic UDI-DIDate29 May 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
UROLUBE - Sterile Lubricant Gel With Lidocaine (CHG Free), 6mL
Model / Reference
UROLUBE - Sterile Lubricant Gel With Lidocaine (CHG Free), 6mL, 25pcs/box, UL-L 006
Primary DI / UDI-DI
18698703333984
Basic UDI-DI
B-18698703333984
EMDN Code
U040199 Devices for suprapubic urinary drainage - other
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017811

Other devices from İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Incorporates Medicinal Product
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No

Sources (1)

  • EUDAMED 69c7e5d8-3a0e-4447-a53d-a3e76d4628c7 61 fields · synced 24 Oct 2026