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UROMED Transurethral Continuous Irrigation Silicone Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref 2085.20
Identity
- Trade Name
- UROMED Transurethral Continuous Irrigation Silicone Balloon Catheter EUDAMED
- Device Name
- PBC01 EUDAMED
- Model / Reference
- 2085.20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098802444 EUDAMED
- Basic UDI-DI
- B-04250098802444 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
UROMED Transurethral Continuous Irrigation Silicone Balloon Catheter by UROMED Kurt Drews KG — Class IIa — MDD — listed in EUDAMED
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
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-04250098802444 | Class IIa | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED 0575d55c-3bbd-4ab0-9361-23a28f56d99c 61 fields · synced Jun 18, 2026