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FecalSwab

by Copan Italia S.P.A.

Ref 4U031S

FecalSwab (4U031S) is an in vitro diagnostic device (EU IVDD general IVD; EU IVDD Class A) made by Copan Italia S.P.A., registered in EUDAMED on 4 May 2026 (Basic UDI-DI B-28053326002704), active as of 25 Oct 2026.

Active European Union

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-28053326002704 Basic UDI-DI Date4 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device name
2mL modified Cary Blair in bulk plus stool transfer device in bulk
Model / reference
4U031S
Primary DI / UDI-DI
28053326002704, 18053326002707
Basic UDI-DI
B-28053326002704, 80533260CD0140AM0028K
EMDN code
W0104010203, W050301020101
Device class
Class IVD General
Class A
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000022535

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Properties

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