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UROMED Transurethral Silicone Balloon Catheter
EUDAMEDClass IIb (EU MDR)
Ref 1091.16
Identity
- Trade Name
- UROMED Transurethral Silicone Balloon Catheter EUDAMED
- Device Name
- TBC01 EUDAMED
- Model / Reference
- 1091.16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098819138 EUDAMED
- Basic UDI-DI
- 04250098810030EB EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER 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 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 | 04250098810030EB | Class IIb | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED e1c8b492-e1d1-48cb-a37a-82cfe5b33c42 61 fields · synced Jun 19, 2026