Identity
- Trade Name
- UriSponge™ EUDAMEDUriSponge EUDAMED
- Device Name
- UriSponge™ Urine transport and preservation system, vial 12x80 EUDAMEDUriSponge EUDAMEDUriSponge Mini – Urine Collection, Transport & Preservation System EUDAMEDUriSponge Mini – Urine Collection, Transport & Preservation System single pouch EUDAMEDUriSponge – Urine Collection, Transport & Preservation System - Automation EUDAMED
- Model / Reference
- 802CE.A EUDAMED802C EUDAMED802CS01 EUDAMED803CE.A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 28053326000533 EUDAMED08053326000539 EUDAMED28053326004487 EUDAMED38053326004491 EUDAMED28053326004500 EUDAMED
- Basic UDI-DI
- 80533260CD0160AM0019K EUDAMEDB-28053326004487 EUDAMEDB-38053326004491 EUDAMEDB-28053326004500 EUDAMED
- Unit of Use DI
- 08053326000539 EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass 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
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen collection kit
UriSponge™ by Copan Italia S.P.A. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 80533260CD0160AM0019K | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 80533260CD0160AM0019K | Class A | Active |
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Manufacturer
- Manufacturer
- Copan Italia S.P.A.
- EUDAMED SRN
- IT-MF-000022535
Sources (5)
- EUDAMED 9df45ff0-0ca3-4da5-8aad-79e003259abb 61 fields · synced Jul 22, 2026
- EUDAMED 6660b6ca-6eee-4854-a448-bd180a580c4f 61 fields · synced Jul 10, 2026
- EUDAMED 9dc65550-54cd-49b7-8e92-d223162d3fb9 61 fields · synced Jul 13, 2026
- EUDAMED 654cff63-e16c-4514-aa21-882ddad8aca6 61 fields · synced Jul 21, 2026
- EUDAMED abe25efc-a74e-48b4-acbb-636dd816c044 61 fields · synced Jul 22, 2026