# FecalSwab

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/fecalswab-r-4u031s>
- Manufacturer: [Copan Italia S.P.A.](https://devicerts.com/manufacturers/copan-italia-s-p-a) (Italy)
- Device class: IVD General (EU IVDD); Class A (EU IVDD)
- EMDN: W0104010203 TRANSPORT MEDIA
- EMDN: W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-28053326002704 · registered 2026-05-04 · status: Active

## Recalls

No recall on record.

## Identity

- Device name: 2mL modified Cary Blair in bulk plus stool transfer device in bulk [EUDAMED]
- Model / reference: 4U031S [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 28053326002704 [EUDAMED]; 18053326002707 [EUDAMED]
- Basic UDI-DI: B-28053326002704 [EUDAMED]; 80533260CD0140AM0028K [EUDAMED]
- EMDN code: W0104010203 [EUDAMED]; W050301020101 [EUDAMED]

## Classification

- Device class: Class IVD General [EUDAMED]; Class A [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]; Standard device [EUDAMED]
- EU market of registration: Italy [EUDAMED]

## Properties

- Supplied sterile: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Reagent: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]

## Source and citation

- Cite as: FecalSwab, Copan Italia S.P.A. deviCERTS medical device catalogue. https://devicerts.com/devices/fecalswab-r-4u031s (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/fecalswab-r-4u031s.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/fecalswab-r-4u031s
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.