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UriSponge™

by Copan Italia S.P.A.

Ref 802CE.A

UriSponge (802CE.A) is an in vitro diagnostic device (EU IVDD Class A; EMDN category samples analyses) made by Copan Italia S.P.A., registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI 80533260CD0160AM0019K), active as of 22 Oct 2026.

Active European Union

CE IVDR CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number80533260CD0160AM0019K Basic UDI-DI Date9 Apr 2026RegisteredStatusActive
European UnionCE/IVDR Number80533260CD0160AM0019K Basic UDI-DI Date9 Apr 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device name
UriSponge™ Urine transport and preservation system, vial 12x80
Model / reference
802CE.A
Primary DI / UDI-DI
28053326000533, 08053326000539
Basic UDI-DI
80533260CD0160AM0019K
Unit of use DI
08053326000539
EMDN code
W050301020101 Samples analyses, plastic tubes with additives
Device class
Class A
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022535

Related devices

Category: General specimen collection kit

Similar devices in this category

Other devices filed under ANALYSIS CONTAINERS.

Other devices from Copan Italia S.P.A.

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

Properties

  • Supplied sterile
  • Professional testing YesEUDAMEDNoEUDAMED
Other properties (11, all answered No)