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UriSponge

by Copan Italia S.P.A. Italy EUDAMED

Ref 803CE.A

EMDN W050301020101

Regulatory status

as of 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-28053326004500 Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
UriSponge – Urine Collection, Transport & Preservation System - Automation
Model / Reference
803CE.A
Primary DI / UDI-DI
28053326004500
Basic UDI-DI
B-28053326004500
EMDN Code
W050301020101 Samples analyses, plastic tubes with additives
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022535

Related devices

Category: General specimen collection kit

Other devices from Copan Italia S.P.A.

See all devices from Copan Italia S.P.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Professional Testing
Other properties (8)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED abe25efc-a74e-48b4-acbb-636dd816c044 61 fields · synced 22 Oct 2026