UROMED PROSIL Transurethral Continuous Irrigation Silicone Balloon Catheter
by UROMED Kurt Drews KG 18 variants
Ref 2370.20
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-04250098830829 04250098830829 | Date5 Feb 2026 | StatusActive |
| European Union | CE/MDD | NumberB-04250098830829 04250098830829 | Date5 Feb 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- PBC01
- Model / Reference
- 2370.20
- Primary DI / UDI-DI
- 04250098830829
- Basic UDI-DI
- B-04250098830829, 04250098810072ET
- EMDN Code
- U010204 Urethral prostatic and bladder catheters, dufour, with balloon
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006084
Other devices from UROMED Kurt Drews KG
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No