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UROMED SILUCENT Transurethral Silicone Balloon Catheter
EUDAMEDClass IIb (EU MDR)
Ref 1104.22
Identity
- Trade Name
- UROMED SILUCENT Transurethral Silicone Balloon Catheter EUDAMED
- Device Name
- TBC02 EUDAMED
- Model / Reference
- 1104.22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098800822 EUDAMED
- Basic UDI-DI
- 04250098810035EM 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 SILUCENT 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 | 04250098810035EM | Class IIb | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED 5ba77374-078e-4ab5-98eb-fb783e756ff0 61 fields · synced Jun 19, 2026