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Uromed

by Manish Medi Innovation Private Limited EUDAMED

Active European Union

Ref BSS4824OEModel DJS4726OE

Overview

Meet the UROMED, a revolutionary double J catheter (stent) device designed for safe and effective placement in patients undergoing endovascular procedures. Our device has been rigorously tested to ensure its sterility, sterility testing results indicate it meets FDA standards. The UROMED is a standard medical device that has been approved for use in the market since 2020.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890615570DJSPR Basic UDI-DIDate11 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
DJS4726OE, BSS4824OE
Primary DI / UDI-DI
08906155703198
Basic UDI-DI
890615570DJSPR
Direct Marketing DI
08906155703198
EMDN Code
U020399 Ureteral stents - other
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
IN-MF-000039093
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Manish Medi Innovation Private Limited

See all devices from Manish Medi Innovation Private Limited →

Properties

  • 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