Identity
- Trade Name
- UriSponge™ FDA UDI
- Generic Name
- Non-evacuated urine specimen container IVD, preservative FDA UDI
- Device Name
- UriSponge™ - Urine Collection, Transport, and Preservation System 80mm length x 12mm diameter FDA UDI
- Model / Reference
- 8U033S50 FDA UDI
- Description
- UriSponge™ - Urine Collection, Transport, and Preservation System 80mm length x 12mm diameter FDA UDI
Identifiers
- Catalog Number
- 8U033S50 FDA UDI
- Primary DI / UDI-DI
- 38053326011710 FDA UDI
- 510(k) Number
- K232565 FDA UDI
- FDA Product Code
- JSM FDA UDILIO FDA UDI
- GMDN Term
- Non-evacuated urine specimen container IVD, preservative FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 FDA UDI866.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-evacuated urine specimen container IVD, preservative
UriSponge™ by Copan Italia Spa — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Non-evacuated urine specimen container IVD, preservative.
- Urine Monovette Boric Acid 3, 2 ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Urine Monovette Boric Acid 8, 5 ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Urine Monovette Boric Acid 3, 2 ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Urine Monovette® 10ml bor.acid — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Urine Monovette® 10ml bor.acid — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Starplex — Pretium Canada Packaging ULC · Class I
- Urine Monovette Boric Acid 8, 5 ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- LBM® UriSponge™ — COPAN ITALIA SPA · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Copan Italia Spa
Sources (2)
- FDA UDI b9530b4a-33a3-4794-9791-5d33dfe7dab0 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026