Identity
- Trade Name
- FecalSwab® EUDAMEDFecalSwab EUDAMED
- 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
- Basic UDI-DI
- B-28053326002704 EUDAMED
- EMDN Code
- W0104010203 TRANSPORT MEDIA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
FecalSwab® by Copan Italia S.P.A. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-28053326002704 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Copan Italia S.P.A.
- EUDAMED SRN
- IT-MF-000022535
Sources (2)
- EUDAMED f599228f-dfe7-4d66-8c03-2ad0990f305f 61 fields · synced Jul 29, 2026
- EUDAMED 49bff868-fa52-4a30-b7cc-291c4e399d74 61 fields · synced Jul 29, 2026