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UROMED Transurethral Tamponade Silicone Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref 1870.22Ref 1770.20Ref 1770.22Ref 1770.24Ref 1771.22Ref 1871.20Ref 1771.20
Identity
- Trade Name
- UROMED Transurethral Tamponade Silicone Balloon Catheter EUDAMED
- Device Name
- PBC01 EUDAMED
- Model / Reference
- 1870.22 EUDAMED1770.20 EUDAMED1770.22 EUDAMED1770.24 EUDAMED1771.22 EUDAMED1871.20 EUDAMED1771.20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098802147 EUDAMED04250098801935 EUDAMED04250098801966 EUDAMED04250098801997 EUDAMED04250098802055 EUDAMED04250098802208 EUDAMED04250098802024 EUDAMED
- Basic UDI-DI
- B-04250098802147 EUDAMEDB-04250098801935 EUDAMEDB-04250098801966 EUDAMEDB-04250098801997 EUDAMEDB-04250098802055 EUDAMEDB-04250098802208 EUDAMEDB-04250098802024 EUDAMED
- EMDN Code
- U010204 URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON EUDAMEDU010203 URETHRAL PROSTATIC AND BLADDER CATHETERS, DELINOTTE, 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-04250098802147 | Class IIa | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (7)
- EUDAMED 50cf59b9-70ff-4625-b28e-1a698c138fde 61 fields · synced Oct 6, 2026
- EUDAMED 4d792ed4-ae3d-42c0-b48c-f069f4a4ee14 61 fields · synced May 17, 2026
- EUDAMED 5f0cb77a-1bfe-4148-82a1-507a00bbe7e0 61 fields · synced May 17, 2026
- EUDAMED 59bd9fea-4fb8-4109-8e49-91494741ec70 61 fields · synced May 18, 2026
- EUDAMED d7c22f79-4d68-460b-8f47-ab25a12a01c4 61 fields · synced May 18, 2026
- EUDAMED a34419f2-d7dd-4079-84ed-79eee994227d 61 fields · synced May 18, 2026
- EUDAMED 1c1a653b-bd40-49c7-8b96-802e5eddba3c 61 fields · synced May 19, 2026