UROMED Transurethral Tamponade Silicone Balloon Catheter
by UROMED Kurt Drews KG 6 variants
Ref 1870.18
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-04250098802086 04250098802086 | Date5 Feb 2026 | StatusActive |
| European Union | CE/MDD | NumberB-04250098802086 04250098802086 | 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- Withdrawn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
- 1870.18
- Primary DI / UDI-DI
- 04250098802086
- Basic UDI-DI
- B-04250098802086, 04250098810071ER
- 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