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UROMED Transurethral Tamponade Silicone Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref 1870.20
Identity
- Trade Name
- UROMED Transurethral Tamponade Silicone Balloon Catheter EUDAMED
- Device Name
- PBC01 EUDAMED
- Model / Reference
- 1870.20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098802116 EUDAMED
- Basic UDI-DI
- B-04250098802116 EUDAMED
- EMDN Code
- U010204 URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UROMED Transurethral Tamponade Silicone Balloon Catheter by UROMED Kurt Drews KG — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250098802116 | Class IIa | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED d76746b1-0def-4add-98cf-f3329731db35 61 fields · synced Jun 19, 2026