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UROMED PROSIL Transurethral Silicone Balloon Catheter
EUDAMEDClass IIb (EU MDR)
Ref 1108.16
Identity
- Trade Name
- UROMED PROSIL Transurethral Silicone Balloon Catheter EUDAMED
- Device Name
- TBC03 EUDAMED
- Model / Reference
- 1108.16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098827768 EUDAMED
- Basic UDI-DI
- 04250098810032EF EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIb 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 PROSIL Transurethral Silicone Balloon Catheter by UROMED Kurt Drews KG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 04250098810032EF | Class IIb | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED bbe0b6e2-ea42-405e-bb50-6be6d17323fd 61 fields · synced Jun 17, 2026